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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 | S003 |
Date Received | 08/03/1998 |
Decision Date | 11/02/1998 |
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(R) Model 3057 Test Stimulation Lead Bulk Accessory/Medtronic(R) Model 3065U Test Stimulation Lead Kit for use with the Medtronic(R) Interstim(R) Continence Control System which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. |