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 | SNS Urinary: InterStim Therapy System and 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 | S289 |
Date Received | 04/26/2019 |
Decision Date | 05/24/2019 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement to use the new Loctite DAG 1050 material and to increase the graphite target solids concentration in the DAG material solution at Medtronic Tier II supplier, AVX Biddeford |
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