Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | InterStim® Sacral Nerve Stimulation Therapy System (Urinary Control ) |
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 | S253 |
Date Received | 08/21/2017 |
Decision Date | 02/07/2018 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00547378
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updates to incorporate 5 year data from the InSite Post-Approval Study (Single Tined Lead (protocol 1634). |
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