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, Verify Evaluation 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 | S282 |
Date Received | 12/26/2018 |
Decision Date | 03/08/2019 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in material purity of niobium wire stock; second-tier raw material supplier change for niobium wire stock; lubricant change for wire drawing process; and process change to anneal wire prior to wire drawing process. |
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