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 THERAPY SYSTEMS |
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 | S124 |
Date Received | 07/25/2011 |
Decision Date | 04/10/2012 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE LABELING TO ALLOW PARTICULAR TYPES OF MRI SCANS TO BE PERFORMED WHILE THE DEVICES ARE IMPLANTED AND FOR ASSOCIATED CHANGES IN THE PRODUCT SPECIFICATION OF MODEL 3023 INTERSTIM NEUROSTIMULATOR. |
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