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Device | MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE, N.E. MINNEAPOLIS, MN 55432 |
PMA Number | P970004 |
Supplement Number | S002 |
Date Received | 02/27/1998 |
Decision Date | 07/08/1998 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for marketing the Medtronic InterStim(R) Model 3023 Implantable Pulse Generator (IPG) and its control devices (model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod(R)) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. |