| Attribute | Value |
|---|---|
| Trade Name | INTERSTIM II NEUROSTIMULATOR |
| Generic Name | IMPLANTABLE SYSTEM FOR SACRAL NERVE STIMULATION |
| Applicant | MEDTRONIC INC. |
| PMA Number | P970004 |
| Supplement Number | S132 |
| Date Received | Mar 26, 2012 |
| Decision Date | Apr 25, 2012 |
| Product Code | EZW |
| Advisory Committee | GU |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS. |
| Trade Name/Applicant | Suppl. Reason/Type | Suppl. No. | Decision Date |
|---|---|---|---|
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S131 | Apr 20, 2012 |
| INTERSTIM MEDTRONIC INC. | 30-DAY NOTICE | S130 | Apr 12, 2012 |
| INTERSTIM THERAPY SYSTEMS MEDTRONIC INC. | LABELING CHANGE - INSTRUCTIONS NORMAL 180 DAY TRACK | S124 | Apr 10, 2012 |
| INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S129 | Jan 31, 2012 |
| INTERSTIM NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S128 | Jan 20, 2012 |
| INTERSTIM LEADS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S127 | Jan 13, 2012 |
| INTERSTIM II MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S126 | Dec 28, 2011 |
| INTERSTIM II INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S112 | Nov 09, 2011 |
| INTERSTIM THERAPY SYSTEMS MEDTRONIC INC. | SPECIAL(IMMEDIATE TRACK) | S125 | Aug 26, 2011 |
| INTERSTIM SYSTEM MEDTRONIC INC. | LOCATION CHANGE: STERILIZER NORMAL 180 DAY TRACK NO USER FEE | S121 | Aug 25, 2011 |
| INTERSTIM II, MODEL 3058 NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S108 | Aug 19, 2011 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S122 | Aug 17, 2011 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | 30-DAY NOTICE | S123 | Aug 17, 2011 |
| INTERSTIM FAMILY OF INS/LEADS/EXTENSION MEDTRONIC INC. | PROCESS CHANGE: PACKAGING 30-DAY NOTICE | S120 | Aug 05, 2011 |
| INTERSTIM FAMILY OF INS/LEADS/EXTENSION MEDTRONIC INC. | 30-DAY NOTICE | S119 | Jul 29, 2011 |
| INTERSTIM FAMILY OF INS/LEADS/EXTENSION MEDTRONIC INC. | PROCESS CHANGE - OTHER 30-DAY NOTICE | S118 | Jul 07, 2011 |
| INTERSTIM II NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S117 | Jul 06, 2011 |
| INTERSTIM FAMILY MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S115 | Jun 22, 2011 |
| INTERSTIM/INTERSTIM II INS MEDTRONIC INC. | PROCESS CHANGE: STERILIZATION 30-DAY NOTICE | S114 | Jun 17, 2011 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S113 | Jun 16, 2011 |
| MODEL 3058 INTERSTIM 2 NEUROSTIMULATOR MEDTRONIC INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT NORMAL 180 DAY TRACK | S087 | Jun 09, 2011 |
| INTERSTIM SACRAL NERVE STIMULATION SYSTEM MEDTRONIC INC. | LABELING CHANGE - INSTRUCTIONS SPECIAL(IMMEDIATE TRACK) | S116 | Jun 08, 2011 |
| INTERSTIM II INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S109 | May 06, 2011 |
| 3058 INTERSTIM II INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S111 | May 06, 2011 |
| INTERSTIM/INTERSTIM II NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: PACKAGING 30-DAY NOTICE | S110 | May 04, 2011 |
| MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR MEDTRONIC INC. | DESIGN CHANGE - MINOR REAL-TIME PROCESS | S104 | Apr 04, 2011 |
| INTERSTIM INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S107 | Mar 17, 2011 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE - OTHER 30-DAY NOTICE | S105 | Mar 09, 2011 |
| INTERSTIM/INTERSTIM II INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S106 | Mar 09, 2011 |
| INTERSTIM THERAPY SYSTEM MEDTRONIC INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT REAL-TIME PROCESS | S098 | Jan 11, 2011 |
| INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT MEDTRONIC INC. | PROCESS CHANGE - OTHER 30-DAY NOTICE | S103 | Jan 07, 2011 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/MAGNET MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S102 | Jan 05, 2011 |
| INTERSTIM II NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S101 | Dec 29, 2010 |
| INTERSTIM INS MEDTRONIC INC. | PROCESS CHANGE - OTHER 30-DAY NOTICE | S100 | Dec 23, 2010 |
| INTERSTIM INS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S099 | Dec 22, 2010 |
| INTERSTIM/INTERSTIM II NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S097 | Nov 24, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE - OTHER 30-DAY NOTICE | S096 | Nov 10, 2010 |
| INTERSTIM THERAPY/INTERSTIM II MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S095 | Nov 02, 2010 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S093 | Oct 14, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S092 | Oct 01, 2010 |
| INTERSTIM PATIENT PROGRAMMER MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S091 | Sep 10, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S090 | Jul 29, 2010 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S089 | Jul 20, 2010 |
| INTERSTIM II MODEL 3058 DEVICE MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S088 | Jul 14, 2010 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S086 | Jun 30, 2010 |
| INTERSTIM ICON PATIENT PROGRAMMER MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S085 | May 20, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S084 | Apr 30, 2010 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD& KIT MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S083 | Apr 16, 2010 |
| INTERSTIM THERAPY SYSTEM MEDTRONIC INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT REAL-TIME PROCESS | S079 | Apr 13, 2010 |
| INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093 MEDTRONIC INC. | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL NORMAL 180 DAY TRACK NO USER FEE | S082 | Apr 02, 2010 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY MEDTRONIC INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT REAL-TIME PROCESS | S077 | Mar 03, 2010 |
| INTERSTIM QUADRIPOLAR EXTENSION/INTERSTIM TEST KIT MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S081 | Mar 03, 2010 |
| INTERSTIM/INTERSTIM II IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S080 | Feb 26, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S078 | Feb 12, 2010 |
| MEDTRONIC INTERSTIM THERAPY MEDTRONIC INC. | DESIGN CHANGE - MINOR REAL-TIME PROCESS | S069 | Jan 14, 2010 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S076 | Jan 13, 2010 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC INC. | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL NORMAL 180 DAY TRACK | S073 | Oct 26, 2009 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS MEDTRONIC INC. | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK NO USER FEE | S075 | Oct 15, 2009 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S074 | Jul 10, 2009 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC INC. | LABELING CHANGE - INSTRUCTIONS NORMAL 180 DAY TRACK | S064 | Apr 30, 2009 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S072 | Apr 30, 2009 |
| INTERSTIM FAMILY OF NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S071 | Mar 12, 2009 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S070 | Mar 02, 2009 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC INC. | LABELING CHANGE - MINOR REAL-TIME PROCESS | S062 | Jan 30, 2009 |
| INTERSTIM FAMILY OF NEUROSTIMULATORS MEDTRONIC INC. | PROCESS CHANGE: STERILIZATION 30-DAY NOTICE | S068 | Jan 26, 2009 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC INC. | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK NO USER FEE | S065 | Jan 16, 2009 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S066 | Jan 14, 2009 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S067 | Jan 05, 2009 |
| INTERSTIM THERAPY MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S063 | Nov 25, 2008 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC INC. | PROCESS CHANGE: STERILIZATION 135 REVIEW TRACK FOR 30-DAY NOTICE | S060 | Oct 17, 2008 |
| INTERSTIM II NEUROSTIMULATOR MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S050 | Aug 18, 2008 |
| INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80 MEDTRONIC NEUROMODULATION | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER REAL-TIME PROCESS | S056 | Jul 03, 2008 |
| INTERSTIM II MODEL 3058 NEUROSTIMULATOR MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S057 | Jun 27, 2008 |
| MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01 MEDTRONIC NEUROMODULATION | LABELING CHANGE - INSTRUCTIONS REAL-TIME PROCESS | S054 | May 30, 2008 |
| INTERSTIM FAMILY OF NEUROSTIMULATORS MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S055 | May 22, 2008 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC NEUROMODULATION | PROCESS CHANGE: STERILIZATION 30-DAY NOTICE | S053 | Apr 25, 2008 |
| MEDTRONIC INTERSTIM THERAPY MEDTRONIC NEUROMODULATION | LABELING CHANGE - INSTRUCTIONS REAL-TIME PROCESS | S049 | Apr 24, 2008 |
| INTERSTIM II NEUROSTIMULATOR MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S052 | Apr 18, 2008 |
| INTERSTIM II NEUROSTIMULATOR MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S051 | Apr 10, 2008 |
| INTERSTIM NEUROSTIMULATOR MEDTRONIC NEUROMODULATION | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S048 | Mar 26, 2008 |
| INTERSTIM THERAPY MEDTRONIC NEUROMODULATION | 30-DAY NOTICE | S047 | Jan 17, 2008 |
| INTERSTIM FAMILY OF NEUROSTIMULATOR MEDTRONIC NEUROLOGICAL | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S042 | Jan 11, 2008 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC INC. | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S045 | Dec 18, 2007 |
| INTERSTIM FAMILY OF NEUROSTIMULATOR MEDTRONIC INC. | PROCESS CHANGE: STERILIZATION 30-DAY NOTICE | S046 | Dec 11, 2007 |
| INTERSTIM NEUROSTIMULATOR MEDTRONIC NEUROLOGICAL | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S044 | Nov 08, 2007 |
| INTERSTIM FOR URINARY CONTROL MEDTRONIC NEUROLOGICAL | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE REAL-TIME PROCESS | S041 | Nov 07, 2007 |
| MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093 MEDTRONIC VASCULAR | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL NORMAL 180 DAY TRACK NO USER FEE | S040 | Oct 23, 2007 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC NEUROLOGICAL | LABELING CHANGE - INSTRUCTIONS SPECIAL(IMMEDIATE TRACK) | S043 | Oct 15, 2007 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - OTHER NORMAL 180 DAY TRACK NO USER FEE | S037 | Aug 31, 2006 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S033 | Jun 30, 2006 |
| INTERSTIM FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE REAL-TIME PROCESS | S039 | Jun 27, 2006 |
| INTERSTIM MEDTRONIC VASCULAR | PROCESS CHANGE: MANUFACTURING 135 REVIEW TRACK FOR 30-DAY NOTICE | S034 | Feb 21, 2006 |
| INTERSTIM-THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | DESIGN CHANGE - MINOR REAL-TIME PROCESS | S035 | Dec 23, 2005 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR MEDTRONIC VASCULAR | PROCESS CHANGE: STERILIZATION 30-DAY NOTICE | S036 | Nov 08, 2005 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE MEDTRONIC VASCULAR | LOCATION CHANGE: STERILIZER NORMAL 180 DAY TRACK | S029 | Aug 04, 2005 |
| INTERSTIM SYSTEM MEDTRONIC VASCULAR | LABELING CHANGE - INSTRUCTIONS SPECIAL(IMMEDIATE TRACK) | S032 | May 27, 2005 |
| MEDTRONIC INTERSTIM TINED LEAD MEDTRONIC VASCULAR | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL NORMAL 180 DAY TRACK NO USER FEE | S030 | Nov 24, 2004 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM MEDTRONIC VASCULAR | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL NORMAL 180 DAY TRACK NO USER FEE | S025 | Jun 08, 2004 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095 MEDTRONIC VASCULAR | PROCESS CHANGE: MANUFACTURING 30-DAY NOTICE | S028 | May 27, 2004 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - INSTRUCTIONS SPECIAL(IMMEDIATE TRACK) | S027 | Jan 28, 2004 |
| INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS MEDTRONIC VASCULAR | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK NO USER FEE | S026 | Nov 17, 2003 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - INSTRUCTIONS REAL-TIME PROCESS | S024 | Apr 01, 2003 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE NORMAL 180 DAY TRACK | S023 | Jan 23, 2003 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT NORMAL 180 DAY TRACK | S022 | Sep 24, 2002 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - INDICATIONS REAL-TIME PROCESS | S021 | Feb 15, 2002 |
| INTERSTIM SYSTEM FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - MINOR REAL-TIME PROCESS | S020 | Feb 04, 2002 |
| INTERSTIM SYSTEM MEDTRONIC VASCULAR | PROCESS CHANGE: PACKAGING 30-DAY NOTICE | S019 | Dec 14, 2001 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | PROCESS CHANGE: MANUFACTURING SPECIAL(IMMEDIATE TRACK) | S018 | Dec 05, 2001 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LOCATION CHANGE: MANUFACTURER NORMAL 180 DAY TRACK | S017 | Nov 01, 2001 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT NORMAL 180 DAY TRACK | S014 | Oct 24, 2001 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | Express GMP Supplement NORMAL 180 DAY TRACK | S016 | Sep 07, 2001 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S013 | Aug 17, 2001 |
| INTERSTIM(R) THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT NORMAL 180 DAY TRACK | S012 | Aug 06, 2001 |
| INTERSTIM(R) THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - INSTRUCTIONS SPECIAL(IMMEDIATE TRACK) | S015 | Jun 26, 2001 |
| INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY, 3080/3886 LEAD KITS MEDTRONIC VASCULAR | PROCESS CHANGE: STERILIZATION REAL-TIME PROCESS | S011 | Feb 05, 2001 |
| MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT NORMAL 180 DAY TRACK | S009 | Oct 18, 2000 |
| INTERSTIM SYSTEM FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT REAL-TIME PROCESS | S010 | Jun 28, 2000 |
| INTERSTIM SYSTEM FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - MINOR REAL-TIME PROCESS | S008 | Mar 09, 2000 |
| INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY MEDTRONIC VASCULAR | LABELING CHANGE - MINOR REAL-TIME PROCESS | S007 | Feb 29, 2000 |
| INTERSTIM CONTINENCE CONTROL SYSTEM MEDTRONIC VASCULAR | LABELING CHANGE - MINOR REAL-TIME PROCESS | S006 | Nov 04, 1999 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL REAL-TIME PROCESS | S005 | Sep 03, 1999 |
| INTERSTIM THERAPY FOR URINARY CONTROL MEDTRONIC VASCULAR | LABELING CHANGE - INDICATIONS PANEL TRACK | S004 | Apr 15, 1999 |
| MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S003 | Nov 02, 1998 |
| MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM MEDTRONIC VASCULAR | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER NORMAL 180 DAY TRACK | S002 | Jul 08, 1998 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM MEDTRONIC VASCULAR | PROCESS CHANGE: PACKAGING REAL-TIME PROCESS | S001 | Oct 31, 1997 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM MEDTRONIC NEUROMODULATION | Sep 29, 1997 |
Please verify with original source as appropriate.