|
Device | InterStim Therapy System and Verify Evaluation System (SNM Urinary) |
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 | S293 |
Date Received | 06/26/2019 |
Decision Date | 07/25/2019 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alignment of the labeling to an updated Risk Management process. This included addition of adverse events (e.g., changes in sexual function) and additional language to describe the impact of extreme program settings on battery longevity. |