| Trade Name | SCS NEUROSTIMULATORS EXTERNAL, SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE |
| Generic Name | |
| Applicant | MEDTRONIC INC. |
| PMA Number | P840001 |
| Recent Supplement Number | S233 |
| Contact | 7000 CENTRAL AVENUE NE MS RCW235 MINNEAPOLIS, MN, 55432 |
| Date Received | Feb 01, 2013 |
| Decision Date | Feb 25, 2013 |
| Product Code | LGW |
| Advisory Committee | NE |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | UPDATE TO THE LTX TEST SYSTEM SHELL SOFTWARE. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S232 | Feb 14, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE CONNECTOR CLEANING TECHNOLOGY PROCESS. |
| S231 | Jan 08, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION. |
| S230 | Dec 17, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR MINOR CHANGES TO MODEL 8840 NVISION PROGRAMMER SOFTWARE FOR END OF SERVICE AND LOW/ EMPTY RESERVOIR ALARMS. |
| S223 | Dec 03, 2012 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS. |
| S229 | Nov 02, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR. |
| S228 | Oct 24, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA. |
| S227 | Oct 10, 2012 | /30-DAY NOTICE | USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER. |
| S221 | Sep 14, 2012 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MINOR MODIFICATIONS TO THE PACKAGE DIMENSIONS, THE INNER TRAY AND THE RETAINER LID. ALSO REQUESTED WAS A PACKAGE MATERIAL CHANGE FROM POLYVINYL CHLORIDE (PVC) TO POLYETHYLENE TEREPHTHALATE GLYCOL (PETG) FOR THE OUTER TRAY, THE INNER TRAY AND THE RETAINER LID. |
| S226 | Sep 13, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF MANUFACTURING EQUIPMENT AT YOUR MPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR. |
| S225 | Sep 12, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE THE ACCEPTANCE CRITERIA FOR TITANIUM CONTENT IN THE CABLES AND TO ADD AN ALTERNATE SUPPLIER FOR THE CABLE BRAIDING AND MICRO-EXTRUSION PROCESSES. |
| S199 | Sep 06, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC NEUROMODULATION IN MINNEAPOLIS, MINNESOTA. |
| S224 | Aug 22, 2012 | PROCESS CHANGE - OTHER/30-DAY NOTICE | ADDITION OF ANOTHER SUPPLIER FOR THE INNER SEAL SILICONE COMPONENT 117988-001. |
| S220 | Aug 10, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | ADDITION OF A DUPLICATE ETO STERILIZATION SYSTEM. |
| S218 | Aug 01, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | A CHANGE TO THE FINAL FUNCTIONAL TEST. |
| S222 | Aug 01, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | DESIGN CHANGE TO THE POST STERILIZATION TEST SOFWARE. |
| S217 | Jun 15, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | CHANGE TO AUTOMATE THE MANUAL RATE CHECK (POST- STERILIZATION TEST) FOR THE IMPACTED DEVICES. |
| S215 | Jun 08, 2012 | /30-DAY NOTICE | IMPLEMENTATION OF A NEW SEALER USED TO HEAT SEAL ADHESIVE COATED LIDS TO THERMOFORMED PLASTIC BLISTER STYLE TRAYS. |
| S216 | Jun 07, 2012 | /30-DAY NOTICE | UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES. |
| S214 | Jun 05, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS. |
| S211 | May 30, 2012 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704 AND ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS-INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS: 1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FBS OR HERNIATED DISK; 3) POSTLAMINECTOMY PAIN; 4) MULTIPLE BACK OPERATIONS; 5) UNSUCCESSFUL DISK SURGERY; 6) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 7) PERIPHERAL CAUSALGIA; 8) EPIDURAL FIBROSIS; 9) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 10) COMPLEX REGIONAL PAIN SYNDROME (CRPS); 11) REFLEX SYMPATHETIC DYSTROPHY (RSD), OR 11) CAUSALGIA. |
| S213 | May 30, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS. |
| S208 | May 24, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI- FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATOR OF THE RESTORESENSOR NEUROSTIMULATOR, MODEL 37714. |
| S212 | May 10, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC?S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES. |
| S209 | May 02, 2012 | /30-DAY NOTICE | CHANGE IN THE ACCEPTANCE CRITERIA OF THE INSULATED CABLE AND THE QUALIFICATION OF A NEW SUPPLIER. |
| S207 | Apr 25, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS. |
| S206 | Apr 20, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS. |
| S210 | Apr 20, 2012 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION. |
| S205 | Apr 12, 2012 | /30-DAY NOTICE | ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT. |
| S203 | Jan 20, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING. |
| S202 | Jan 13, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS. |
| S201 | Jan 12, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | THREE SOFTWARE CHANGES, AUTOMATION OF THE BOND PAD ARRAY MANUFACTURING PROCESS, AND MINOR CHANGES TO THE ETHYLENE OXIDE RESIDUAL TESTING PROCEDURES. |
| S200 | Dec 28, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC?S HYBRID SUPPLIER. |
| S198 | Dec 12, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | RELOCATION OF PASSIVATION OPERATIONS AND INTRODUCTION OF AN AUTOMATED FLUID TRANSFER PROCESS WITHIN THE EXISTING MEDTRONIC NEUROMODULATION FACILITY ? RICE CREEK CENTRAL. |
| S197 | Nov 10, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MEDTRONIC, INC. MINNEAPOLIS, MN 55432 UPDATE DATA ENTRY DURING THE WAFER TEST PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS. |
| S184 | Nov 09, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS. |
| S185 | Nov 03, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED FOR SPINAL CORD STIMULATION (SCS) AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS: 1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FBS OR HERNIATED DISK; 3) POSTLAMINECTOMY PAIN; 4) MULTIPLE BACK OPERATIONS; 5) UNSUCCESSFUL DISK SURGERY; 6) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 5) PERIPHERAL CAUSALGIA; 6) EPIDURAL FIBROSIS; 7) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; AND 8) COMPLEX REGIONAL PAIN SYNDROME (CRPS), REFLEX SYMPATHETIC DYSTROPHY (RSD), OR CAUSALGIA. |
| S196 | Oct 21, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENT SOFTWARE UPDATES TO THE SELF TEST APPLICATION OF THE NEXT GENERATION TESTER. |
| S195 | Aug 26, 2011 | /SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION. THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES. |
| S193 | Aug 17, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER. |
| S194 | Aug 17, 2011 | /30-DAY NOTICE | UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC?S MANUFACTURING FACILITIES. |
| S192 | Aug 05, 2011 | PROCESS CHANGE: PACKAGING/30-DAY NOTICE | CHANGES TO THE BLISTER SEALING OPERATION AND THE INSPECTION SPECIFICATIONS FOR THAT OPERATION. |
| S191 | Jul 29, 2011 | PROCESS CHANGE - OTHER/30-DAY NOTICE | PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS. |
| S190 | Jul 07, 2011 | PROCESS CHANGE - OTHER/30-DAY NOTICE | UPDATE STATISTICAL PROCESS CONTROL SOFTWARE. |
| S189 | Jul 06, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATING THE WELDING EQUIPMENT SOFTWARE AT A VENDOR. |
| S188 | Jun 22, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN THE FEEDTHROUGH ASSEMBLY |
| S187 | Jun 17, 2011 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | ADDITION OF AN ETHYLENE OXIDE STERILIZER SYSTEM. |
| S186 | Jun 16, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES. |
| S182 | May 06, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | ADDITION OF AN OPTIONAL DEBURRING PROCESS. |
| S183 | May 04, 2011 | PROCESS CHANGE: PACKAGING/30-DAY NOTICE | IMPLEMENTATION OF NEWLY VALIDATED PROCESS PARAMETERS FOR THE BLISTER SEALING MACHINE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN JUNCOS, PUERTO RICO. |
| S159 | Apr 22, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI-FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATORS OF THE DEVICE. |
| S178 | Apr 04, 2011 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2. |
| S181 | Mar 17, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A NEW MANUFACTURING MOLD AND COMPONENT SUPPLIER. |
| S102 | Mar 15, 2011 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MINOR FIRMWARE CHANGE. |
| S179 | Mar 09, 2011 | PROCESS CHANGE - OTHER/30-DAY NOTICE | IMPLEMENTATION OF AN ADDITIONAL AUTOMATED PLATING LINE AT THE PLATING SUPPLIER. |
| S180 | Mar 09, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATION TO EPOXY DISPENSE EQUIPMENT PARAMETERS. |
| S176 | Jan 26, 2011 | /30-DAY NOTICE | CHANGES TO THE MANUFACTURING OF A COMPONENT FLEX CIRCUIT. |
| S175 | Jan 20, 2011 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE |
| S174 | Jan 12, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE BATTERY TESTING CRITERIA. |
| S173 | Jan 07, 2011 | PROCESS CHANGE - OTHER/30-DAY NOTICE | UPGRADE OF SOFTWARE USED FOR MANAGING QUALITY CHECKS AND REPORTING OF INCOMING MATERIALS. |
| S172 | Jan 05, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA. |
| S170 | Dec 23, 2010 | PROCESS CHANGE - OTHER/30-DAY NOTICE | USE OF A NEW MOLD FOR AN INNER SEALING RING COMPONENT AND THE ADDITION OF A SECOND SUPPLIER FOR THE COMPONENT. |
| S171 | Dec 23, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE ELECTRICAL TEST SOFTWARE. |
| S169 | Dec 22, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATE OF AN INSPECTION PROCEDURE AND ACCEPTANCE OF RECEIVING FACILITIES FOR THE INNER AND OUTER MOLDED SEALING RING COMPONENTS. |
| S168 | Nov 24, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM. |
| S167 | Nov 10, 2010 | PROCESS CHANGE - OTHER/30-DAY NOTICE | CHANGE TO A NEW CONTRACT LABORATORY FOR INSPECTION PROCEDURES. |
| S158 | Nov 01, 2010 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR CHANGES TO ELECTRICAL TEST SOFTWARE. |
| S165 | Oct 14, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITIONAL SUPPLIER FOR HYBRID COMPONENTS AND TO QUALIFY TWO SUPPLIERS TO PERFORM SURROGATE INSPECTIONS. |
| S164 | Oct 01, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS. |
| S163 | Sep 16, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATE OF THE SOFTWARE FOR THE LASER RIBBON BONDING (ORB) PROCESSING EQUIPMENT LOCATED AT MEDTRONIC |
| S161 | Sep 10, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS. |
| S162 | Sep 10, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO REMOVE A CONDITIONING PROCEDURE FROM THE PATIENT PROGRAMMERS |
| S160 | Aug 27, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE TEST SOFTWARE USED FOR ELECTRICAL TESTING OF MEDTRONIC?S IMPLANT TABLE NEUROSTIMULATORS. |
| S157 | Jul 29, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS. |
| S156 | Jul 20, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE TRACEABILITY SOFTWARE. |
| S154 | Jun 30, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO AN IN-LINE AUTOMATED OPTICAL INSPECTION (AOI) AND PRESSURIZED NITROGEN GAS CLEANING. |
| S155 | Jun 23, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATIONS AT THE FEEDTHROUGH. |
| S151 | Jun 17, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS. |
| S153 | May 27, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO QUALIFY A CONNECTOR REWORK PROCESS FOR THE DEVICE MANUFACTURING PROCESSES AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO. |
| S152 | May 20, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI). |
| S150 | Apr 30, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A SUPPLIER FOR THE PLANTING PROCESS. |
| S149 | Apr 16, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENTATION OF THE QUALITYHOLD BUSINESS RULE WITHIN THE FACTORY WORKS MANUFACTURING TRACEABILITY SYSTEM. |
| S143 | Mar 04, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR THE MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES. |
| S147 | Mar 03, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A SECOND LASER WELDING WORKSTATION AND POWER SUPPLY. |
| S148 | Mar 03, 2010 | /30-DAY NOTICE | CLEANING OF PIECE PARTS IN A NEW CONTROLLED ENVIRONMENT AREA (CEA) WITHIN THE SAME EXISTING FACILITY. |
| S146 | Feb 26, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO. |
| S145 | Feb 12, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES IN THE COMPONENT INSPECTION PROCEDURES FOR THE DEVICE. |
| S144 | Jan 21, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | INCREASE IN THE PRESS FORCE USED TO FORM THE BATTERY CATHODES WHICH WILL REDUCE THE CATHODE THICKNESS VARIATION AND INCREASE THE YIELD OF THE RX1 BATTERY PRODUCTION. |
| S142 | Jan 13, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | INCREASING THE BAKE TIME FOR CERAMIC SUBSTRATES PRIOR TO THE SOLDER PREP REFLOW AND ADDING AN ADDITIONAL BAKE AFTER THE CLEAN AND DRY PROCESSING STEP. |
| S117 | Dec 04, 2009 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES. |
| S141 | Oct 15, 2009 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR. |
| S140 | Sep 16, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | TRANSFER OF QUADRAFILAR COILS SUPPLIER MANUFACTURING SITE FROM HERAEUS LINO LAKES, MINNESOTA TO DORADO, PUERTO RICO. |
| S135 | Sep 02, 2009 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR: 1) REMOVAL OF THE XYLENE MIXING STEP; 2) ADDITION OF A SECONDARY SILICONE ADHESIVE STEP AND CURE; AND 3) MODIFICATION OF THE INCOMING RECEIVING INSPECTION PROCESS WITH THE ADDITION OF A PROCESS MONITOR. |
| S139 | Jul 10, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE DURATION OF THE DRYING TIME FOR THE ADHESIVE USED IN THE BONDING APPLICATION OF NEUROSTIMULATION LEADS. |
| S138 | Jun 18, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE MANUFACTURING PROCESS OF THE SCREENING CONNECTOR CABLE. |
| S136 | Jun 08, 2009 | PROCESS CHANGE: MANUFACTURING/REAL-TIME PROCESS | APPROVAL FOR MINOR MODIFICATIONS TO THE TORQUE WRENCH AND STYLET ACCESSORIES. |
| S126 | Jun 03, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR MODEL 39565 SPECIFY 5-6-5 LEAD KIT (65CM LENGTH), MODEL 39286 SPECIFY 2X8 SURGICAL LEAD KIT (30CM AND 65CM LENGTHS), AND MODEL 3550-P4 PASSING ELEVATOR ACCESSORY KIT. |
| S134 | May 20, 2009 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR MANUFACTURING CHANGES TO THE SPECIFY 5-6-5 LEAD, MODEL 39565-30. |
| S137 | Apr 30, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO AUTOMATE A MANUFACTURING PROCESS AND THE ADDITION OF VISUAL INSPECTIONS DURING THE PROCESS. |
| S131 | Apr 20, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR MODEL 74001 (1X4) POCKET ADAPTOR AND MODEL 74002 (2X4) POCKET ADAPTOR. |
| S133 | Apr 08, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A HEADER REWORK PROCESS FOR THE DEVICE. |
| S128 | Apr 01, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR REDESIGN OF THE 6-PIN FILTERED FEEDTHROUGH. |
| S132 | Mar 19, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE RESISTANCE WELDING OPERATION. |
| S130 | Mar 12, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE IN-LINE MANUFACTURING TEST FOR SEAM WELD LEAK TEST INSPECTION PROCEDURE. |
| S129 | Mar 02, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ALTERNATE SUPPLIER FOR AN EXTRUDED TUBING COMPONENT. |
| S127 | Jan 26, 2009 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | CHANGE IN THE STERILIZATION PROCESS AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO. |
| S123 | Jan 16, 2009 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONIC, INC., WINONA, MINNESOTA. |
| S124 | Jan 14, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO. |
| S125 | Jan 05, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | INTRODUCTION OF SPRAY WASH EQUIPMENT AND THE MODIFICATION OF THE CLEANING PROCESS. |
| S122 | Dec 08, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE ADDITION OF A STABILIZING COIL TO THE MODEL 37083 EXTENSION, A |
| S121 | Nov 06, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A DUAL PIN PRESS TO THE MANUFACTURING PROCESS. |
| S098 | Nov 05, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR SOFTWARE UPDATES MADE TO N |
| S118 | Oct 17, 2008 | PROCESS CHANGE: STERILIZATION/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY. |
| S119 | Sep 17, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO QUALIFY A SECOND VENDOR. |
| S111 | Sep 12, 2008 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR MULTIPLE MANUFACTURING PROCESS CHANGES. |
| S107 | Aug 18, 2008 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES. |
| S115 | Jul 11, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN AUTOMATED CUTTING MACHINE AND THE ADDITION OF VISUAL INSPECTION STEPS. |
| S114 | Jul 01, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | AUTOMATION OF A MANUFACTURING PROCESS FOR THE RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS. |
| S113 | Jun 10, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADD A NEW COMPONENT VENDOR TO SUPPLY TWO INTEGRATED CIRCUITS (ICS) FOR USE ON THE HYBRIDS IN THE RESTORE FAMILY OF DEVICES. |
| S112 | May 22, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATIONS TO THE STERILIZATION PROCESS. |
| S110 | Apr 25, 2008 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, VILLALBA MANUFACTURING FACILITY. |
| S109 | Apr 18, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A PLASMA CLEANING PROCESS TO DELTA 26H AND RX-1 BATTERY HEADER MANUFACTURING PROCESSES. |
| S108 | Apr 10, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE WORKSTATION USED FOR PERFORMING BUTTON WELDING ON BATTERIES. |
| S106 | Mar 26, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES. |
| S100 | Feb 29, 2008 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR A NEW COMPONENT VENDOR FOR TWO INTEGRATED CIRCUITS (ICS) USED ON THE HYBRID IN THE RESTORE FAMILY OF DEVICES. |
| S105 | Jan 17, 2008 | /30-DAY NOTICE | USE OF AN INSERT-MOLDED PROCESS TO MANUFACTURE THE BOND PAD ARRAY (BPA) IN PLACE OF A PRESS-FIT MANUFACTURING METHOD. |
| S099 | Jan 11, 2008 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS. |
| S097 | Jan 08, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE RESTOREULTRA RECHARGEABLE NEUROSTIMULATION SYSTEM. THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES. |
| S103 | Dec 18, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REMOVAL OF THE THERMAL SHOCK TEST AS PART OF THE BATTERY MANUFACTURING PROCESS. |
| S104 | Dec 11, 2007 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY. |
| S101 | Nov 08, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE WORKSTATION USED FOR WELDING BATTERY HEADER SUBASSEMBLIES. |
| S096 | Jun 11, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 39565 SPECIFY 5-6-5 LEAD KIT. |
| S095 | Mar 07, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A MINOR DESIGN CHANGE TO THE FEEDTHROUGH AND FOR THE USE OF ACETONE FOR THE REMOVAL AND REPLACEMENT OF THE CONNECTOR BLOCK IN THE MANUFACTURING REWORK PROCESS. |
| S093 | Jul 18, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM. |
| S092 | Jul 07, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE RESTORE ADVANCED AND PRIME ADVANCED NEUROSTIMULATION SYSTEMS. THE DEVICES ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES. |
| S090 | Mar 31, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 37082 DUAL QUADRIPOLAR EXTENSION KIT (8-2-4). |
| S089 | Mar 17, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 37701 RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR (INS). |
| S083 | Feb 16, 2006 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS. |
| S091 | Feb 08, 2006 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR REVISED TEXT TO THE CAUTION IN THE "PLACING A PERCUTANEOUS LEAD" SECTION OF THE INSTRUCTIONS FOR USE SECTION OF THE FOLLOWING MANUALS: MODEL 3898 PISCES-OCTAD LEAD KIT IMPLANT MANUAL, MODEL 3487 A PISCES QUAD, MODEL 3887 PISCES QUAD COMPACT, AND MODEL 3888 PISCES QUAD PLUS LEAD KITS IMPLANT MANUAL, AND MODEL 3890 PISCES Z QUAD, MODEL 3891 PISCES Z QUAD COMPACT, AND MODEL 3892 PISCES Z QUAD PLUS LEAD KITS IMPLANT MANUAL. |
| S084 | Jan 30, 2006 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR A FILTERED FEEDTHROUGH. |
| S088 | Jan 26, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR A MODIFICATION OF THE MODEL 37742 PATIENT PROGRAMMER TO ALLOW PATIENTS TO RESET A POWER-ON-RESET (POR) STATUS OF THE EXTERNAL NEUROSTIMULATOR TO THE PHYSICIAN PROGRAMMED SETTINGS. |
| S086 | Nov 30, 2005 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE ETHYLENE OXIDE EXPOSURE TIME. |
| S082 | Nov 04, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 3776 1X8 SC (SUBCOMPACT) LOW IMPEDANCE LEAD KIT AND THE MODEL 3876 1X8 SC LOW IMPEDANCE LEAD KIT. |
| S081 | Oct 20, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 3550-39 TITAN ANCHOR ACCESSORY KIT. |
| S080 | Sep 23, 2005 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 37083, SINGLE QUADPOLAR EXTENSION KIT. |
| S076 | Jun 06, 2005 | LABELING CHANGE - INSTRUCTIONS/NORMAL 180 DAY TRACK | APPROVAL FOR MRI LABELING UPDATES TO THE ABOVE LISTED SPINAL CORD STIMULATION (SCS) SYSTEMS. |
| S075 | Apr 15, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE 1 X 8 LEAD SYSTEM. |
| S077 | Apr 15, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES. |
| S074 | Apr 08, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES. |
| S073 | Jun 16, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A NEW PERMANENTLY IMPLANTED SURGICAL LEAD (MODEL 3999 HINGED 2 X 4 LEAD) TO BE USED WITH MEDTRONICS FULLY IMPLANTABLE NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (P840001) OR THE EXTERNAL RADIO FREQUENCY NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (K934065). |
| S072 | Apr 15, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL TO USE EALSTHANE RESINS AS ALTERNATE MATERIALS TO PELLETHANE RESINS IN LEADS, EXTENSIONS AND ACCESSORIES. THE FOLLOWING LEADS, EXTENSIONS AND ACCESSORIES WILL BE AFFECTED: MODEL 3487A - PISCES QUAD, MODEL 3887 - PISCES QUAD COMPACT, MODEL 3888 - PISCES QUAD PLUS, MODEL 3890 - PISCES Z QUAD, MODEL 3891 - PISCES Z QUAD COMPACT, MODEL 3892 - PISCES Z QUAD PLUS, MODEL 3898 - PISCES OCTAD, MODEL 3998 - SPECIFY, MODEL 3982A - SYMMIX, MODEL 3861 - TEMPORARY SCREENING LEAD, MODEL 3862 - VERIFY, MODEL 3587A - RESUME II, MODEL 3986A RESUMETL, MODEL 7471 EXTENSION, MODEL 7489 EXTENSION, MODEL 7495 EXTENSION, MODEL 7495LZ EXTENSION, MODEL 7496 EXTENSION, MODEL 7498 EXTENSION, MODEL 3550-09 - ACCESSORY KIT, MODEL 7441 - ACCESSORY KIT AND MODEL 7441NC - ACCESSORY KIT. |
| S069 | Jan 06, 2004 | LABELING CHANGE - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR A REVISED LABELING ARCHITECTURE. |
| S071 | Nov 17, 2003 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO. |
| S070 | Sep 17, 2003 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE RESUME II MODEL 3587A, THE RESUME TL MODEL 3986A, THE ON-POINT MODEL 3987A AND THE SYMMIX MODEL 3982A LEADS. |
| S067 | May 09, 2003 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE SNAP LID SCREENING CABLE, THE OCTAD PERCUTANEOUS EXTENSION AND THE OCTAD STYLET WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S068 | May 09, 2003 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO PISCES Z QUAD LEAD TECHNICAL MANUALS AND A CHANGE TO THE NEEDLE IN THE PISCES Z QUAD LEAD KITS AND IN THE MODEL 3550-22 AND MODEL 3550-23 ACCESSORY KITS FROM 15 GAUGE TO THE 14 GAUGE. |
| S061 | Oct 31, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE MODEL 8870 N'VISION APPLICATION CARD. THE MODEL 8870 N'VISION APPLICATION CARD IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S066 | Oct 29, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 7489 EXTENSION WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S065 | Oct 03, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 3898 PISCES-OCTAD LEAD AND THE MODEL 7471 OCTAPOLAR EXTENSION WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S064 | Sep 26, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE MODEL 3890 PISCES Z QUAD LEAD, MODEL 3891 PISCES Z QUAD COMPACT LEAD, MODEL 3892 PISCES Z QUAD PLUS LEAD AND MODEL 3550-22 AND 3550-23 LEAD REVISION KITS. THE DEVICES ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S062 | Jul 25, 2002 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 3550-16 EZ ANCHOR ACCESSORY KIT WHICH WILL BE LABELED FOR USE WITH THE FOLLOWING MEDTRONIC, INC. LEADS: PISCES-QUAD MODEL 3487A, RESUME MODEL 3587A, TEMPORARY SCREENING LEAD MODEL 3861, PISCES-QUAD COMPACT MODEL 3887, PISCES-QUAD PLUS MODEL 3888 AND THE PISCES-OCTAD MODEL 3898. THE MODEL 3550-16 EZ ANCHOR IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S063 | Jun 12, 2002 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR UPDATING THE MAGNETIC RESONANCE IMAGING (MRI) TEXT IN THE SPINAL CORD STIMULATION PAIN THERAPY MANUALS. |
| S060 | Jan 03, 2002 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT. |
| S058 | Dec 14, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTACTABLE PAIN OF THE TRUNK OR LIMBS. |
| S059 | Dec 11, 2001 | PROCESS CHANGE: MANUFACTURING/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS. |
| S055 | Aug 14, 2001 | PROCESS CHANGE: MANUFACTURING/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR AN ADDITIONAL QUALITY CONTROL STEP TO VERIFY THAT THE NEUROSTIMULATORS ARE MANUFACTURED TO THERI SPECIFICATION, I.E. THAT THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM (CASE) SHIELD. |
| S053 | Aug 06, 2001 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 AND MODEL 7495LZ EXTENSIONS. THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO. |
| S052 | Aug 03, 2001 | LABELING CHANGE - INDICATIONS/NORMAL 180 DAY TRACK | APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE FROM "CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS" TO "CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS". THE INDICATION STATEMENT HAS BEEN REVISED TO STATE "THE MEDTRONIC [TRADE NAME] SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD)/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA." |
| S051 | Jul 31, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APROVAL FOR THE MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION WHICH WILL BE USED WITH THE ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS. |
| S050 | Jul 26, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE ITREL(R) EZ(TM) MODEL 7434A PATIENT PROGRAMMER, TO BE USED WITH THE MODEL 7425 ITREL(R) 3 IMPLANTABLE PULSE GENERATOR, AND LABELING MODIFICATIONS RESULTING FROM THE INTRODUCTION OF THE NEW PATIENT PROGRAMMER. |
| S054 | Jun 22, 2001 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH A MEDTRONIC SPINAL CORD STIMULATION SYSTEM. |
| S047 | Feb 21, 2001 | LABELING CHANGE - INDICATIONS/NORMAL 180 DAY TRACK | APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE OF THE MEDTRONIC MODEL 7421 ITREL, 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION SYSTEMS. THESE DEVICES ARE NOW INDICATED "AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BCK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA". |
| S049 | Dec 13, 2000 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | A MANUFACTURING PROCESS CHANGE FROM A RESISTANCE WELD TO A LASER WELD. |
| S045 | Jun 13, 2000 | LABELING CHANGE - INDICATIONS/REAL-TIME PROCESS | APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE FOR MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) DEVICES. THESE DEVICES ARE INDICATED "AS N AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND LIMBS, INCLUDING-CHRONIC AND INTRACTABLE UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK... |
| S046 | Apr 12, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS/REAL-TIME PROCESS | Approval for the Model 7499 Extension, Connector Boot, and Extension Passer Tunneling System, for use in conjunction with the Medtronic Itrel Spinal Cord Stimulation System. Also, approval for labeling modifications. |
| S044 | Mar 21, 2000 | PROCESS CHANGE: MANUFACTURING/REAL-TIME PROCESS | Approval for device and manufacturing process changes to the existing Model 7424 ITREL II Neurostimulator, for use in conjunction with the Medtronic Itrel Spinal Cord Stimulation System. |
| S042 | Nov 19, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | Approval for the Dual Chamber Intrel(R) Synergy(TM) Neurostimulation System as well as the Model 7459 MemoryMod Software for use with the existing Itrel(R) 3 Spinal cord Stimulation System. |
| S043 | Feb 10, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | Approval for revisions to the existing Model 7495 Quadripolar Extension Kit used in conjunction with the Medtronic Itrel Spinal Cord Stimulation System. |
| S041 | Jan 20, 1998 | PROCESS CHANGE: PACKAGING/NORMAL 180 DAY TRACK | Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation. |
| S040 | Apr 25, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR DESIGN CHANGES FOR THE ITREL(R) SERIES OF NEUROLOGICAL PULSE GENERATORS, INCLUDING THE INTREL(R), ITREL(R) II, AND ITREL(R) 3. |
| S039 | Feb 28, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR A Y-EXTENSION (MODEL 7498) AND Y-SCREENING CABLE (MODEL 3552). |
| S038 | Dec 06, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE USE OF SEALING RINGS IN THE MODEL 7495 PERMANENT EXTENSION |
| S032 | Oct 17, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR AN ALTERNATE BEAD BLAST FINISH |
| S037 | Aug 29, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR MEDTRONIC ITREL 3 SPINAL CORD STIMULATION (SCS) SYSTEM FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND OR LIMBS |
| S036 | Jul 13, 1995 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR RELOCATION OF THE STERILIZATION/PACKAGING FACILITY & A MODIFICATION IN THE STERILIZATION PROCESS FOR MODELS:7491,7492,7493,7494,7495,7496 & ASSOCIATED LEADS,RECEIVERS, & ACCESSORIES NEW FACILITY:COLUMBIA HEIGHTS,MINNESOTA 55421 |
| S034 | Apr 27, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S035 | Jan 23, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S031 | Jan 05, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S030 | May 25, 1994 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S029 | Dec 07, 1993 | LABELING CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S026 | Apr 05, 1993 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S028 | Mar 31, 1993 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S025 | Jul 09, 1992 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S022 | Jan 17, 1992 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | |
| S024 | Aug 29, 1991 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S023 | Apr 03, 1991 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S020 | Sep 27, 1990 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S021 | Aug 08, 1990 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S019 | Apr 19, 1990 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | |
| S018 | Apr 06, 1990 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | |
| S016 | Dec 08, 1989 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | |
| S015 | Aug 02, 1989 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S017 | Aug 01, 1989 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | |
| S013 | Nov 29, 1988 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S014 | Nov 10, 1988 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S012 | Sep 15, 1988 | PROCESS CHANGE: PACKAGING/NORMAL 180 DAY TRACK | |
| S011 | Aug 14, 1987 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S010 | Aug 05, 1987 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S009 | Jun 22, 1987 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S008 | Jul 14, 1986 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S006 | Jun 05, 1986 | Original Approval | |
| S007 | Jun 05, 1986 | Original Approval | |
| S005 | Apr 14, 1986 | Original Approval | |
| S004 | Jun 04, 1985 | /NORMAL 180 DAY TRACK | |
| S003 | May 31, 1985 | Original Approval | |
| S002 | Mar 26, 1985 | /NORMAL 180 DAY TRACK | |
| S001 | Feb 07, 1985 | /NORMAL 180 DAY TRACK | |
| Nov 30, 1984 | Original Approval |