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 to update the sterilization dose auditing frequency from every three to 12 months
| Device | ProACT Adjustable Continence Therapy for Men |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | UROMEDICA INC |
| Date Received | 2021-05-18 |
| Decision Date | 2021-06-10 |
| PMA | P130018 |
| Supplement | S002 |
| Product Code | EZY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |