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 | VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL 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 | S187 |
Date Received | 12/29/2014 |
Decision Date | 06/26/2015 |
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 THE MODEL 3579 CABLE AND MODEL 3676 CABLE AND ASSOCIATED CHANGES TO ENABLE USE OF THE APPROVED VERIFY¿ EVALUATION SYSTEM WITH THE APPROVED TEMPORARY TEST STIMULATION LEADS. |
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