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.
Approval of the protocol for the post-approval study protocol.
| Device | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
| Classification Name | Device, Incontinence, Mechanical/hydraulic |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | UROMEDICA INC |
| Date Received | 2015-12-21 |
| Decision Date | 2016-11-02 |
| PMA | P130018 |
| Supplement | S001 |
| Product Code | EZY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UROMEDICA INC 1840 Berkshire Lane N plymouth, MN 55441 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130018 | Original Filing | |
| S002 | 2021-05-18 | 30-day Notice |
| S001 | 2015-12-21 | Normal 180 Day Track No User Fee |