| Trade Name | EON MINI LE CHARGER, EON MINI LE CHARGING SYSTEM |
| Generic Name | IMPLANTABLE PULSE GENERATOR SYSTEM |
| Applicant | ST. JUDE MEDICAL |
| PMA Number | P010032 |
| Recent Supplement Number | S065 |
| Contact | 6901 PRESTON ROAD PLANO, TX, 75024 |
| Date Received | Dec 17, 2012 |
| Decision Date | Jan 16, 2013 |
| Product Code | LGW |
| Advisory Committee | NE |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | METHOD OF REMANUFACTURING OF THE CHARGER. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S059 | Jan 09, 2013 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL THE REVISION TO THE MANUFACTURING PROCESS FOR EON MINI (MODEL 3788) IMPLANTABLE PULSE GENERATOR HEADERS. |
| S064 | Dec 04, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE ELECTRODE CUTTING PROCESS. |
| S055 | Oct 25, 2012 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY. |
| S058 | Sep 14, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE MODIFICATION TO THE MODEL 3721 EON MINI CHARGING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 3720 EON MINI LE CHARGER AND MODEL 3722 EON MINI LE CHARGING SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND CHRONIC LOW BACK/LEG PAIN. |
| S062 | Aug 31, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE THE IN- PROCESS DIMENSIONAL INSPECTION FOR THE DEVICES. |
| S057 | Aug 24, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR A CHANGE TO THE INTERNAL BATTERY HOUSING MATERIAL FROM TITANIUM TO 304L STAINLESS STEEL. |
| S060 | Aug 10, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | SOFTWARE REVISION TO AN IN-PROCESS INSPECTION STEP. |
| S056 | Aug 01, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE IN-PROCESS AND FINAL INSPECTION IMPEDANCE TEST. |
| S053 | Jul 31, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834). |
| S054 | Jul 12, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL TO REVERSE THE GENDER OF THE CONTACTS OF THE PLUG AND RECEPTACLE ON THE PORTABLE CHARGER (MODELS 3711 AND 3715) I.E., A RECEPTACLE FOR CONNECTING THE CHARGING ANTENNA WILL NOW HAVE FEMALE PINS FOR CONTACTS, WHILE THE MATING PLUG ON THE CHARGING ANTENNA WILL NOW HAVE MALE CONTACTS. ADDITIONALLY, IT WAS REQUESTED TO CHANGE THE PIN-OUT CONNECTOR FROM A 3 PIN VERSION TO A 4 PIN VERSION. |
| S052 | Jun 22, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE AXXESS LEAD FUNCTIONAL TEST PROCEDURE. |
| S051 | May 17, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | WELDING PROCESS CHANGE FOR THE DEVICE. |
| S049 | Apr 25, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | STERILIZATION MANUFACTURING PROCESS CHANGES FOR ST. JUDE MEDICAL NEUROMODULATION DIVISION PRODUCTS. |
| S048 | Apr 10, 2012 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR MODIFICATIONS TO THE ELECTRODE DESIGN ON THE S-SERIES LAMITRODE LEAD MODELS 3243, 3246, 3283, 3286, 3266 AND 3268. |
| S047 | Mar 02, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE CHARGING ANTENNA AND PORTABLE CHARGING ANTENNA. |
| S045 | Jan 19, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURING PROCESS CHANGE TO ADD AN IN-PROCESS INSPECTION STEP FOR THE DEVICES. |
| S044 | Jan 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADD A BACKSIDE LAMINATION TO COMPONENTS INSTALLED ON THE PRINTED CIRCUIT BOARD (PCB). |
| S043 | Nov 03, 2011 | PROCESS CHANGE: PACKAGING/30-DAY NOTICE | IMPLEMENT A NEW POUCH SEALER TO SEAL ALL TERMINALLY STERILIZED POUCHES. |
| S039 | Nov 02, 2011 | PROCESS CHANGE - OTHER/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL TO ADD AN ELECTRONIC SWITCH SUPPLIER FOR THE DEVICE. |
| S041 | Oct 28, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A MODIFICATION TO THE AMPLITUDE BUTTON OF THE PATIENT PROGRAMMER THAT ADDED MATERIAL TO PREVENT OFF-CENTER ACTUATIONS. |
| S038 | Sep 20, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL TO ADD AN ALTERNATE SUPPLIER FOR THE FEED THROUGH ASSEMBLY. |
| S040 | Aug 12, 2011 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO INCLUDE ADDITIONAL INFORMATION REGARDING BATTERY PASSIVATION IN THE EON C IPG DIRECTIONS FOR USE. |
| S037 | Feb 24, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR ANTENNA SPACER DISKS, WHICH ARE NEW ACCESSORIES FOR THE ALREADY APPROVED MODEL 3701 EON WALL CHARGER KIT. |
| S036 | Feb 11, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR ADDING HEAT SHRINK TUBING (HST) TO THE CONDUCTORS OF THE COAXIAL CABLE OF THE CHARGING ANTENNA WHICH IS USED WITH THE EON IPG SYSTEM. |
| S034 | Nov 19, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE ADDITION OF CRIMP RINGS IN THE STRAIN RELIEFS OF THE EXTERNAL PROGRAMMING WAND CABLE TO IMPROVE RELIABILITY. |
| S035 | Nov 17, 2010 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES THAT CLARIFY THE SURGICAL PROCEDURES USED TO IMPLANT PADDLE LEADS. |
| S032 | Apr 08, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR THE INCORPORATION OF A COLOR ADDITIVE TO CHANGE THE COLOR OF THE POCKET SIZER TO YELLOW, SO THAT IT WOULD BE MORE EASILY VISIBLE TO THE PHYSICIAN. |
| S031 | Jul 31, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE RAPID PROGRAMMER SOFTWARE VERSION 3.3.0. |
| S029 | Jun 01, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR PENTA LEAD KITS (MODELS 3227, 3228, 3229, 3230, 3231, 3232, 3233, AND 3234). |
| S028 | Mar 19, 2009 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO, LLC, IN CAGUAS, PUERTO RICO. |
| S025 | Jan 29, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A MOBILE, BATTERY POWERED, CHARGING SYSTEM THAT IS DESIGNED TO CHARGE THE GENESISRC NEUROSTIMULATION (IPG) SYSTEM AND THE EON NEUROSTIMULATION (IPG) SYSTEM. |
| S027 | Jan 10, 2009 | /30-DAY NOTICE | CHANGE IN THE CLEANING PROCEDURE. |
| S026 | Jul 29, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR ANS TRIPOLE 16 LAMITRODE LEAD MODELS 218, 3219, 3220, AND 3221. |
| S023 | Mar 28, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE EONMINI IPG NEUROSTIMULATION SYSTEM (MODEL 3788), WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S024 | Feb 07, 2008 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR CHANGES TO THE LABELING FOR THE QUIKLINK CONTROLLER, MODEL 3860. |
| S019 | Dec 13, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR INCREASING THE BATTERY LONGEVITY CLAIM FOR SEVEN YEARS TO 10 YEARS. |
| S021 | Dec 10, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE USE OF THE ANS EONC (IPG) NEUROMODULATION SYSTEM, MODEL 3688 WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMB, INCLUDING UNILATERAL AND BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND INTRACTABLE LOW BACK AND LEG PAIN. |
| S022 | Nov 05, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE PEEK-OPTIMA ANTENNA COVER. |
| S020 | Jun 11, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE USE OF THE TRIPOLE 8, TRIPOLE 8C, TRIPOLE 16C, AND EXCLAIM 8 LAMITRODE SERIES LEADS (MODELS 3208, 3210, 3214, 3224) WITH THE GENESIS, GENESIS RC, GENESIS XP, AND EON NEUROSTIMULATION SYSTEMS, WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S018 | Dec 21, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE 90 CM AND 110 CM LENGTH VERSIONS OF THE ANS 3100 AND 3200 SERIES LEADS, WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S017 | Nov 16, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE RAPID PROGRAMMER, MODELS 3830 AND 3831, WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S013 | May 11, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE ADDITION OF FOUR MODELS OF THE S-SERIES LAMITRODE LEADS AS ACCESSORIES TO THE GENESIS FAMILY OF NEUROSTIMULATION IPG DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S-SERIES LAMITRODE LEADS (MODEL NUMBERS3243, 3246, 3283 AND 3286) AND IS INDICATED FOR USE AS THE LEAD COMPONENT OF A SPINAL CORD STIMULATION SYSTEM. THE SPINAL CORD STIMULATION SYSTEM IS USED TO AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR EXTREMITIES. |
| S016 | May 05, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE GENESIS DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG), MODEL 3643 WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S014 | Mar 04, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE EON NEUROSTIMULATION SYSTEM, MODEL 3716, WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S012 | Nov 09, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE GENESIS RC NEUROSTIMULATION SYSTEM, MODEL 3708, AND THE GENESIS RC DUAL (IPG) SYSTEM, MODEL 3744, WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S011 | May 05, 2004 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED NEUROMODULATION SYSTEMS, INC., PLANO, TEXAS. |
| S010 | Apr 15, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE USE OF THE C-SERIES LAMITRODE SPINAL CORD STIMULATION LEADS, MODEL NUMBERS 3245 (LAMITRODE 44C) AND 3289 (LAMITRODE 88C) FOR USE WITH THE ANS GENESIS NEUROSTIMLATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S009 | Jan 20, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE USE OF THE AXXESS PERCUTANEOUS LEAD MODELS 4143, 4146, 4153 AND 4156 WITH THE ANS GENESIS NEUROSTIMULATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S008 | Aug 22, 2003 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE USE OF THE MODEL A127 LEAD EXTENSION (MODELS 2341, 2342, 2343 AND 2346) WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S007 | Mar 05, 2003 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE RAPID PROGRAMMER WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S005 | Dec 23, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE QUICK LINK CONTROLLER MODEL 3860 FOR USE WITH THE GENESIS MODEL 3608, 3609, 3644 AND 3604 IMPLANTED PULSE GENERATORS WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S006 | Dec 23, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS/REAL-TIME PROCESS | APPROVAL FOR THE GENESIS G4 NEUROSTIMULATION (IPG) SYSTEM (MODEL 3604) WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S003 | Sep 18, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR THE MODEL 3811 PAINDOC COMPUTERIZED SUPPORT SYSTEM, VERSION 2.01 FOR USE WITH THE GENESIS MODEL 3850 PATIENT PROGRAMMER WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| S002 | Jul 16, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE GENESIS XP NEUROSTIMULATION SYSTEM AND GENESIS XP DUAL NEUROSTIMULATION SYSTEM WHICH 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |
| Nov 21, 2001 | Original Approval | APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM. THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET. THE DEVICE 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN. |