| Trade Name | VNS THERAPY PULSE/PULSE DUO GENERATOR |
| Generic Name | |
| Applicant | CYBERONICS, INC. |
| PMA Number | P970003 |
| Recent Supplement Number | S155 |
| Contact | 100 CYBERONICS BLVD. HOUSTON, TX, 77058 |
| Date Received | Nov 21, 2012 |
| Decision Date | Feb 25, 2013 |
| Product Code | LYJ |
| Advisory Committee | NE |
| Supplement Type | 135 REVIEW TRACK FOR 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | APPROVAL FOR A MODIFICATION TO THE ELECTRICAL TEST SYSTEM (ETS) SOFTWARE USED IN PRODUCTION. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S156 | Feb 07, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURING CHANGE FOR THE THERAPY GENERATORS. |
| S154 | Feb 01, 2013 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR AN UPGRADE OF THE PROGRAMMING SOFTWARE TO VERSION 10.0, A NEW PROGRAMMING COMPUTER AND CORRESPONDING ADAPTER CABLE, AND REVISION OF THE HIGH IMPEDANCE THRESHOLD. |
| S153 | Oct 30, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE AND THE USE OF ALTERNATE COMPONENTS ON THE PRINTED CIRCUIT BOARD FOR THE PROGRAMMING WAND. |
| S152 | Sep 13, 2012 | PROCESS CHANGE - OTHER/30-DAY NOTICE | USE OF ALTERNATE SCHOTTKY DIODES FOR THE VNS THERAPY IMPLANTABLE PULSE GENERATORS AND THE PROGRAMMING WAND. |
| S151 | Sep 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A FIXTURE FOR CLEANING OF A COMPONENT. |
| S150 | Jul 26, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATES TO THE ELECTRICAL TEST SYSTEM SOFTWARE FOR VARIOUS MODELS OF THE VNS THERAPY SYSTEM PULSE GENERATORS. |
| S148 | Jul 23, 2012 | /REAL-TIME PROCESS | APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD. |
| S149 | Jun 20, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | NEW ROUTING FIXTURE IN THE MANUFACTURE OF THE PULSE GENERATOR PRINTED CIRCUIT BOARD ASSEMBLY. |
| S147 | Apr 13, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | INTRODUCTION OF AN ADDITIONAL RECEIVING INSPECTION FOR THE TORQUE WRENCH THAT IS PACKAGED WITH THE VNS THERAPY SYSTEM GENERATORS. |
| S145 | Feb 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | INTRODUCTION OF WORK INSTRUCTIONS TO ALLOW REWORK AND REPLACEMENT OF COMPONENTS IN THE VNS THERAPY SYSTEM. |
| S144 | Feb 01, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | THREE CHANGES TO THE MANUFACTURING PROCESS FOR THE PULSE GENERATOR IN THE DEVICE. |
| S143 | Jan 18, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE PARALLEL GAP WELDING STEP DURING THE MANUFACTURING OF THE LEADS FOR THE DEVICE. |
| S142 | Dec 23, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | TWO REVISIONS TO THE SOFTWARE USED IN THE AUTOMATED FUNCTIONAL TEST SYSTEM (AFT) FOR THE VNS THERAPY SYSTEM PULSE GENERATORS. |
| S140 | Dec 20, 2011 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR : 1) REMOVAL OF THE CR10 AND CR11 TVS DIODES FROM THE PCBA DESIGN; AND 2) A CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) SPECIFICATION TO ACCEPT VIAS (VERTICAL ELECTRICAL CONNECTIONS BETWEEN DIFFERENT LAYERS OF CONDUCTORS ON A PCB) FILLED WITH EPOXY FROM THE PCB VENDOR, WHICH IS CURRENTLY ALLOWED FOR THE MODEL 103/104 PULSE GENERATORS. |
| S141 | Dec 02, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A REWORK STEP FOR SOLDERING OPERATIONS OF LIGHT EMITTING DIODES (LEDS) TO PRINTED CIRCUIT BOARDS (PCBS). |
| S139 | Nov 09, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE WELDING PARAMETERS FOR THE VNS PULSE GENERATORS. |
| S135 | Oct 31, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR AN UPGRADE TO THE COMMUNICATION FLASH LOADER (CFL) PORTION OF THE FIRMWARE OF THE DEMIPULSE IMPLANTABLE PULSE GENERATORS, MODEL 103 AND MODEL 104. |
| S138 | Oct 27, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) SOFTWARE. |
| S137 | Oct 21, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE ACCEPTANCE CRITERIA FOR THE MODEL 102/102R PULSE GENERATORS. |
| S136 | Oct 18, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO INVENTORY CONTROL AND TRACEABILITY OF COMPONENTS AND SUBASSEMBLIES. |
| S065 | Oct 17, 2011 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR LABELING CHANGES RELATED TO THE USE OF MRI SYSTEMS WITH THE DEVICE. |
| S134 | Sep 09, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITIONAL SPOT WELDING MACHINE. |
| S133 | Aug 31, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO ADD ADDITIONAL TESTING FOR THE FLASH MEMORY CARDS. |
| S117 | Aug 26, 2011 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYBERONICS IN AUSTIN, TEXAS. |
| S131 | Aug 11, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO MODIFY THE ELECTRICAL TEST SYSTEM SOFTWARE. |
| S132 | Aug 04, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF A NEW PIECE OF EQUIPMENT FOR A QUALITY SYSTEMS TEST. |
| S130 | Jul 29, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A MODIFICATION TO THE SERIAL ADAPTER CABLE POWER CONNECTOR. |
| S129 | Jul 20, 2011 | PROCESS CHANGE - OTHER/30-DAY NOTICE | UPGRADE OF THE AUTOMATED FUNCTIONAL TEST SYSTEM. |
| S128 | Jul 11, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF A NEW LASER MARKER IN THE MANUFACTURING PROCESS OF THE PULSE GENERATORS. |
| S127 | Jun 03, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MAKE CHANGES TO SOFTWARE USED IN AN ELECTRICAL TESTING SYSTEM. |
| S126 | May 20, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A THREAD GAUGING PROCESS TO THE HEADER ATTACHMENT PROCESS AND THE MODIFICATION OR FINAL INSPECTION PROCESS. |
| S125 | Apr 29, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATION OF VISUAL INSPECTION ACCEPTANCE CRITERIA FOR THREE CAPACITORS |
| S124 | Apr 19, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | REVISION TO THE TEST TAB ROUTING STEPS. |
| S123 | Mar 25, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE PULSE GENERATOR MANUFACTURING PROCESS. |
| S122 | Mar 02, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A CLEANING STEP FOR THE PRINTED CIRCUIT BOARD. |
| S121 | Feb 28, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE PULSE GENERATOR MANUFACTURING PROCESS. |
| S120 | Feb 17, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF ALTERNATE RAW MATERIALS AND REMOVAL OF ASSOCIATED CLEANING STEPS. |
| S119 | Jan 21, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE ASPIRE HC MODEL 105 GENERATOR. |
| S118 | Dec 17, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATIVE MANUFACTURING PROCESS MATERIAL AND SUPPLIER. |
| S116 | Nov 23, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR DESIGN MODIFICATIONS AND ASSOCIATED LABELING CHANGES TO THE PROGRAMMING SOFTWARE, MODEL 250 PROGRAMMING SOFTWARE. |
| S115 | Nov 18, 2010 | LABELING CHANGE - INSTRUCTIONS/REAL-TIME PROCESS | APPROVAL FOR CHANGES TO BATTERY LONGEVITY DESIGN REQUIREMENTS AND RELATED LABELING OF BATTERY LONGEVITY TABLES FOR YOUR MODEL 102 AND 102R PULSE GENERATORS. |
| S110 | Nov 05, 2010 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL TO CHANGE THE GENERATOR CLEANING PROCESS. |
| S114 | Oct 13, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | AN ALTERNATE CLEANING PROCESS FOR PRINTED CIRCUIT BOARDS. |
| S112 | Sep 17, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR UPGRADING THE OPERATING SYSTEM OF THE DELL X5 HANDHELD COMPUTER. |
| S113 | Sep 10, 2010 | PROCESS CHANGE - OTHER/30-DAY NOTICE | ADDITION OF A SUPPLIER IN THE STERILIZATION PROCESS. |
| S111 | Aug 04, 2010 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S109 | May 18, 2010 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS). |
| S108 | Apr 14, 2010 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES FOR END OF SERVICE (EOS) WARNING AND LOW IMPEDANCE WARNING. |
| S104 | Jul 23, 2009 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S106 | Mar 06, 2009 | LABELING CHANGE - TRADE NAME/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR CHANGING THE TRADE NAME OF THE VNS THERAPY PERENNIA MODEL 303 LEAD TO VNS THERAPY PERENNIADURA MODEL 303 LEAD. |
| S105 | Feb 23, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | APPROVAL TO ADD AN ADDITIONAL AUTOMATED ELECTRICAL TEST TO THE MANUFACTURING PROCESS. |
| S100 | Dec 19, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVED MODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"): 1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVE FATIGUE RESISTANCE; 2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE AND ABRASION RESISTANCE; 3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND 4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES. |
| S103 | Dec 19, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE |
| S102 | Nov 12, 2008 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES THAT INCLUDE THE ADDITION OF CONFIRMATORY TESTING INFORMATION, STRENGTHENING OF WARNINGS, AND FORMATTING REVISIONS. |
| S101 | Oct 28, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE HANDHELD REWORK PROCESS. |
| S099 | Oct 09, 2008 | PROCESS CHANGE: STERILIZATION/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR STERILIZATION OF MIXED LOADS. |
| S083 | May 01, 2008 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY. |
| S098 | Apr 03, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED. |
| S097 | Feb 29, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A PULSE GENERATOR SOFTWARE COMMUNICATION FLASH LOADER (CFL) TO THE MANUFACTURING PROCESS OF THE DEMIPULSE (MODEL 103) AND DEMIPULSE DUO PULSE (MODEL 104) PULSE GENERATORS. |
| S096 | Feb 22, 2008 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO THE DEMIPULSE AND PULSE DUO GENERATOR, MODELS 103 AND 104 WHICH PROVIDE INSTRUCTIONAL STEPS IN THE EVENT THAT THE USER ENCOUNTERS A MESSAGE THAT THE PULSE GENERATOR IS CURRENTLY DISABLED. |
| S093 | Dec 21, 2007 | PROCESS CHANGE: MANUFACTURING/REAL-TIME PROCESS | APPROVAL FOR AN ALTERNATE COMPONENT TO THE DEMIPULSE (MODEL 103) AND DEMIPULSE DUO (MODEL 104) PULSE GENERATORS PRINTED CIRCUIT BOARD (PCB) ASSEMBLY. |
| S090 | Dec 20, 2007 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR REVISIONS TO THE POST-APPROVAL STUDY. |
| S091 | Dec 20, 2007 | OTHER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR REVISIONS TO THE POST-APPROVAL STUDY. |
| S094 | Dec 19, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADD ADDITIONAL DETAILS TO THE INSPECTION CRITERIA FOR DELAMINATION AND CONSTRAINED COIL IN LEAD MODELS 302 AND 303. |
| S095 | Dec 19, 2007 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR CHANGES CONSISTING OF ADDING ?SEROMA? AS AN ADDITIONAL POSSIBLE ADVERSE EVENT IN THE EPILEPSY AND DEPRESSION INFORMATION MODULES AND ADDING A NOTE DESCRIBING POSSIBLE RISKS WITH REPLACING A LARGER PULSE GENERATOR WITH A SMALLER ONE IN THE REVISION/ REPLACEMENT/ REMOVAL MODULE. |
| S077 | Dec 14, 2007 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYBERONICS, HOUSTON, TEXAS. |
| S092 | Nov 14, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN AUTOMATED ELECTRICAL TEST STATION. |
| S085 | Oct 23, 2007 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR THE POST-APPROVAL STUDY. |
| S089 | Oct 11, 2007 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE ADDITION OF INSTRUCTIONS TO THE TROUBLESHOOTING SECTION IN THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.1 AND MINOR CORRESPONDING CHANGES TO THE HANDHELD COMPUTER CONNECTION INSTRUCTIONS (HP JORNADA, DELL AXIM X5 AND X50). |
| S088 | Sep 21, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITIONAL QUALITY CONTROL TEST. |
| S087 | Sep 04, 2007 | /30-DAY NOTICE | ADDITION OF A NEW MODEL PACKAGING SYSTEM FOR THE DEVICE. |
| S086 | Aug 30, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR A MATERIAL CHANGE TO THE MODEL 220 PATIENT ESSENTIALS KIT PATIENT MAGNET. |
| S076 | Jun 29, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE VNS THERAPY DEMIPULSE, MODEL 103 GENERATOR AND VNS THERAPY DEMIPULSE DUO, MODEL 104 GENERATOR. |
| S079 | Jun 29, 2007 | LABELING CHANGE - SHELF-LIFE/REAL-TIME PROCESS | APPROVAL FOR SHELF LIFE EXTENSION FROM ONE TO TWO YEARS. |
| S084 | Jun 28, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE FROM A DIRECT METALLIZATION PROCESS TO AN ELECTROLESS COPPER METHOD FOR THE PRINTED CIRCUIT BOARD MANUFACTURING PROCESS. |
| S082 | Jun 15, 2007 | PROCESS CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL TO ADD TWO ADDITIONAL IN-PROCESS QUALITY INSPECTION TESTS IN ORDER TO PROVIDE ADDITIONAL ASSURANCE OF RELIABILITY OF THE MODEL 102 AND MODEL 102R PULSE GENERATORS. |
| S081 | May 14, 2007 | LABELING CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL TO ADD ADDITIONAL PRECAUTIONARY INFORMATION TO THE MODEL 300 LEAD PHYSICIAN?S MANUAL AS AN ERRATA SHEET AND TO REVISE THE MODEL 102, 102R, 302 AND 303 VNS THERAPY PHYSICIAN?S MANUAL MODULE ENTITLED ?INTRODUCTION TO THE VNS THERAPY (SYSTEM INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS).? |
| S080 | May 10, 2007 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFY THE CURRENT MANUFACTURING PROCESS OF THE NCP PROGRAMMING WANDS, MODEL 201 BY ADDING AN AUTOMATED VERSION OF THE FINAL ELECTRICAL TEST PROCESS. |
| S078 | Apr 12, 2007 | LABELING CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE ADDITION OF DETAILED INFORMATION CONTAINED IN THE APPROVED TEST TO THE FIGURES PROVIDED IN THE LABELING TO PROVIDE FURTHER CLARIFICATION CONCERNING THE PROPER LEAD IMPLANT TECHNIQUE. ADDITIONALLY, FURTHER DETAILS WERE PROVIDED TO STRESS THE IMPORTANCE OF PROPER STRAIN RELIEF PLACEMENT (I.E. PROPER TIE-DOWN LOCATION AND STRAIN RELIEF BEND). |
| S075 | Feb 12, 2007 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR THE POST-APPROVAL STUDY. |
| S068 | Feb 08, 2007 | PROCESS CHANGE: STERILIZATION/NORMAL 180 DAY TRACK | APPROVAL FOR USE OF AN ADDITIONAL STERILIZATION METHOD. |
| S072 | Nov 02, 2006 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REPROCESSING OF THE NCP PROGRAMMING WANDS FOR MODEL 201. |
| S073 | Nov 02, 2006 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REPROCESSING OF THE HANDHELD COMPUTERS FOR THE VNS THERAPY SYSTEM, MODEL 250 PROGRAMMING SOFTWARE. |
| S074 | Oct 31, 2006 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE ADDITION OF A PRECAUTION TO THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.6.1 AND MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.0 IN THREE DIFFERENT PLACES IN EACH OF THE RESPECTIVE MANUALS. |
| S071 | Oct 17, 2006 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE FOLLOWING CHANGES TO THE LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN PULSE GENERATOR AND LEAD LABELING: 1) THE ADDITION OF A MANUAL ENTITLED, ?REVISION/REPLACEMENT/REMOVAL PROCEDURE MANUAL?. 2) THE INCORPORATION OF THE PHYSICIAN?S MANUAL FOR THE MODEL 303 LEAD INTO THE HARMONIZED LABELING WHICH INCLUDES THE ADDITION OF THE MODULAR PHYSICIAN?S MANUAL ENTITLED, ?TECHNICAL INFORMATION ? VNS THERAPY PERENNIA MODEL 303 LEAD?. 3) REVISIONS TO THE ?IMPLANTATION PROCEDURE? MODULE. |
| S070 | Sep 05, 2006 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR A CHANGE FROM ADDING A STRAIN RELIEF GROMMET TO THE SERIAL DATA CABLE OF THE MODEL 201 PROGRAMMING WAND DURING FINAL ASSEMBLY TO MOLDING AN IMPROVED STRAIN RELIEF ONTO THE SERIAL DATA CABLE DURING ITS MANUFACTURE AND CHANGES TO THE TIE-DOWN USED IN THE MODEL 302 LEAD, THE MODEL 303 LEAD, AND THE MODEL 502 ACCESSORY PACK. |
| S069 | Aug 09, 2006 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL PROTOCOL REVISION FOR THE DEVICE. |
| S063 | Jun 29, 2006 | LABELING CHANGE - INSTRUCTIONS/REAL-TIME PROCESS | APPROVAL FOR LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN, PULSE GENERATOR, LEAD AND PATIENT KIT LABELING. |
| S067 | Jun 22, 2006 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE JOINING PROCESS FOR THE LEAD MODEL 303. |
| S066 | Jun 08, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE MODEL 250 PROGRAMMING SOFTWARE VERSION 7.1. |
| S064 | May 04, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE VNS THERAPY PERENNIA MODEL 303 LEAD. |
| S062 | Dec 28, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.2 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS. |
| S059 | Nov 08, 2005 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S060 | Nov 08, 2005 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S058 | Sep 29, 2005 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES. |
| S050 | Jul 15, 2005 | LABELING CHANGE - INDICATIONS/PANEL TRACK | APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS. |
| S057 | Apr 29, 2005 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR TEXT CHANGES TO THE PRINTED INSTRUCTION CARD. |
| S055 | Feb 01, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.0 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS. |
| S051 | Apr 29, 2004 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK AND APPROVAL FOR A THREE YEAR SHELF LIFE FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK. |
| S053 | Mar 03, 2004 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES IN THE MANUFACTURING PROCESS TO PROPOSE USING CYBERONICS, INC. AS AN ADDITIONAL IN-HOUSE FACILITY FOR BIOBURDEN TESTING ON PRODUCTS AND REDUCING THE FREQUENCY OF SAMPLING OF TUNNELING TOOLS AND ACCESSORY PACKS. |
| S054 | Mar 03, 2004 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURING PROCESS CHANGE TO REDUCE THE MINIMUM VACUUM BAKE PROCESS TIME FOR THE CYBERONICS MODELS 102/102R PULSE GENERATORS. |
| S052 | Dec 23, 2003 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE LOCATION OF THE PERFORMANCE OF THE ENVIRONMENTAL TESTING. |
| S049 | Nov 20, 2003 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR CHANGES TO SIMPLIFY THE LANGUAGE IN THE PATIENT'S MANUAL. |
| S048 | Oct 22, 2003 | LABELING CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR A CHANGE TO THE PRECAUTION REGARDING BRADYCARDIA AND/OR ASYSTOLE. |
| S046 | Sep 30, 2003 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 401 TUNNELER AND APPROVAL OF A PROTOCOL FOR B1 INCUBATION REDUCTION AND SHELF LIFE STUDY, AS WELL AS A NEW STERILIZATION FACILITY (CYBERONICS, INC., HOUSTON, TEXAS). |
| S047 | Aug 14, 2003 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM MODEL 102R GENERATOR, HUMAN FACTORS IMPROVEMENTS TO THE MODEL 102 GENERATOR AND LABELING CHANGES TO THE MODEL 302 LEAD WHICH ARE INDICATED FOR USE AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS. |
| S045 | Feb 28, 2003 | LABELING CHANGE - INSTRUCTIONS/REAL-TIME PROCESS | APPROVAL FOR THE FOLLOWING LABELING CHANGE TO THE INDIVIDUALIZATION OF TREATMENT SECTION OF THE MODEL 100/101 AND 102 PHYSICIAN'S MANUALS "PRECLINICAL STUDY, TERATOGENIC EFFECTS; THERE ARE NO ADEQUATE AND WELL-CONTROLLED STUDIES OF VNS IN PREGNANT WOMEN. REPRODUCTION STUDIES HAVE BEEN PERFORMED USING FEMALE RABBITS STIMULATED WITH THE COMMERCIALLY AVAILABLE VNS THERAPY SYSTEM AT STIMULATION DOSE SETTINGS SIMILAR TO THOSE USED FOR HUMANS. THESE ANIMAL STUDIES HAVE REVEALED NO EVIDENCE OF IMPAIRED FERTILITY OR HARM TO THE FETUS DUE TO VNS THERAPY. BECAUSE ANIMAL REPRODUCTION STUDIES ARE NOT ALWAYS PREDICTIVE OF HUMAN RESPONSE AND ANIMAL STUDIES CANNOT ADDRESS DEVELOPMENTAL ABNORMALITIES, VNS SHOULD BE USED DURING PREGNANCY ONLY IF CLEARLY NEEDED. ALTHOUGH THE OPERATING RANGES OF THE VNS THERAPY SYSTEM AND FETAL MONITORS ARE DISSIMILAR AND NO INTERACTION WOULD BE EXPECTED, TESTING HAS NOT BEEN PERFORMED. THEREFORE, THE POTENTIAL MAY EXIST FOR INTERACTION BETWEEN THE VNS THERAPY SYSTEM AND FETAL MONITORING SYSTEMS." |
| S042 | Jul 29, 2002 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MINOR LABELING MODIFICATIONS TO THE EXISTING MODEL 100/101 NCP PULSE GENERATOR PHYSICIAN'S MANUAL. |
| S040 | Jun 20, 2002 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 101 (VERSION 2) IN-LINE NCP PULSE GENERATOR AND MODEL 302 (VERSION 1) IN-LINE NCP BIPOLAR LEAD, RESULTING IN THE NEW VNS THERAPY PULSE, MODEL 102 GENERATOR AND THE VNS THERAPY LEAD, MODEL 302 (VERSION 1.1). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VNS THERAPY SYSTEM. |
| S039 | Jun 18, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502. |
| S041 | Jun 18, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE VERSION 6.1 (BUILD 4), RESULTING IN THE NEW VERSION 6.1 (BUILD 5). |
| S038 | Mar 28, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE, RESULTING IN NEW VERSIONS 4.6 AND 6.1. |
| S037 | Feb 22, 2002 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MATERIAL OF THE SEPTUM USED ON THE MODEL 101 NCP PULSE GENERATOR. |
| S035 | Sep 04, 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 THE NEUROCYBERNETIC PROSTHESIS (NCP(R)) SYSTEM. |
| S034 | Jun 29, 2001 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 101 IN-LINE PULSE GENERATOR (VERSION 2.0), MODEL 302 IN-LINE BIPOLAR LEADS (VERSION 1.0), MODEL 402 IN-LINE TUNNELING TOOL (VERSION 1.0 AND LABELING CHANGES. |
| S033 | Jun 07, 2001 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES. THE CHANGES ARE INTENDED TO: 1) ADD A WARNING THAT RECOMMENDS THAT PHYSICIANS USE CARE WHEN TREATING PATIENTS WITH PRE-EXISTING OBSTRUCTIVE SLEEP APNEA (OSA), AND 2) ADD AND STRENGTHEN PRECAUTIONS REGARDING: A) ELECTROSURGERY, B) THERAPEUTIC ULTRASOUND, C) EXPOSURE TO ENVIRONMENTS THAT ARE PROTECTED BY A WARNING NOTICE PREVENTING ENTRY BY PATIENTS WITH AN IMPLANTED PACEMAKER, AND D) APPLICATION OF OTHER THERAPIES INVOLVING ELECTRIC CURRENT, SUCH AS TENS DEVICES. |
| S032 | May 10, 2001 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERITEC, INC., ATHENS, TEXAS, AS WELL AS LABELING PROCESS AND PACKAGING CHANGES, AND A COMBINED MODEL PHYSICIAN'S MANUAL. |
| S031 | May 01, 2001 | LABELING CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM MODEL 300 NCP BIPOLAR LEAD (SINGLE RIBBON ELECTRODE). |
| S030 | Feb 27, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE SYSTEM MODEL 250 NCP PROGRAMMING SOFTWARE (VERSION 6). |
| S027 | Aug 24, 2000 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | CHANGE IN THE STERILIZATION LOAD CONFIGURATION FROM USING A 3-TOTE LOAD TO A 12-TOTE LOAD. |
| S026 | Jul 19, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 400S NCP TUNNELING TOOL (FOR USE WITH THE NCP SYSTEM). |
| S025 | Feb 16, 2000 | LABELING CHANGE - INSTRUCTIONS/REAL-TIME PROCESS | Changes to the approved patient labeling for the NCP system. |
| S024 | Dec 18, 1999 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | Approval for labeling changes to enhance the safety of Model 400 NCP Tunneling Tool. |
| S022 | May 05, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | Approval for the Model 101 NCP Pulse Generator (for use with Model 201 NCP Programming Wand and Model 250 NCP Programming Software Version 4.4). |
| S019 | Apr 05, 1999 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, Texas manufacturing facility to the existing Houston, Texas (Space Center) manufacturing facility. |
| S020 | Apr 05, 1999 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-Day Notice requested relocation of the Feed Through Welding Equipment fromt he Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility. |
| S021 | Apr 05, 1999 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-Day Notice requested relocation of the Laser Marking Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility. |
| S016 | Feb 18, 1999 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | Approval for the Model 201 NCP Programming Wand (for use with Model 100 NCP Pulse Generator Versions B and C). |
| S018 | Feb 18, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | Approval for the Model 250 NCP Programming Software Version 4.4 (for use with Model 100 NCP Pulse Generator Versions B and C). |
| S015 | Jan 28, 1999 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX. |
| S017 | Jan 28, 1999 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-Day Notice requested to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the Pulse Generator to a can lid. |
| S014 | Jan 20, 1999 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | Approval for labeling changes being made to the Model 100 NCP PUlse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System. |
| S012 | Dec 18, 1998 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS/REAL-TIME PROCESS | Approval for the Model 250 NCP Programming Software Version 4.3 (for use with Model 100 NCP Pulse Generator Versions B and C). |
| S013 | Dec 18, 1998 | PROCESS CHANGE: PACKAGING/REAL-TIME PROCESS | Approval for the Model 500 NCP Accessory Pack. |
| S011 | Oct 16, 1998 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | The 30-day Notice requested that a welding process be added to the firms' internal manufacturing capabilities. This process is equivalent to the welding process already performed by Cyberonics' subcontractors. The process is being brougth in-house in order to simplify the manufacturing process, improve control of product flow, and improve product availability. |
| S010 | Sep 25, 1998 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | 30-day notice requested the addition of a cleanroom equivalent to one already in use. |
| S008 | Mar 13, 1998 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | |
| S009 | Mar 13, 1998 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | |
| S004 | Jan 29, 1998 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | Approval for NCP(R) Model 100C Pulse Generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name NCP(R) Model 100C Pulse Generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications. |
| S003 | Nov 21, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | Approval for the Model 250 NCP Software Version 5.0 modification. |
| S002 | Oct 09, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | Approval for the modified NCP(R) System Lead Connector Boot Design and the NCP(R) System Programming Software Version 4.1. |
| S005 | Oct 09, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | Approval for the modified NCP(R) System Lead Connector Boot Design and the NCP(R) System Programming Software Version 4.1. |
| S001 | Aug 21, 1997 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK | Approval for a manufacturing site located at Texcel, Inc., 55 Deer Park Drive, E. Longmeadow, MA 01028. |
| Jul 16, 1997 | Original Approval | Approval for the NeuroCybernetic Prosthesis (NCP(R)) System which includes the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool, and NCP System Accessories. |