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 System and Verify Evaluation System (SNS Urinary Programming 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 | S302 |
Date Received | 10/07/2019 |
Decision Date | 07/30/2020 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval of the new InterStim Micro System with 1.5T and 3T full-body MR conditional labeling, an updated InterStim II System (including new SureScan MRI leads) with 1.5T and 3T full-body MR conditional labeling, an updated Verify Evaluation System that can accommodate newly developed leads, and related labeling updates. |
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