This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the proact adjustable continence therapy for men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (turp) and who have failed to respond adequately to conservative therapy.
| Device | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
| Classification Name | Device, Incontinence, Mechanical/hydraulic |
| Generic Name | Device, Incontinence, Mechanical/hydraulic |
| Applicant | UROMEDICA INC |
| Date Received | 2013-06-17 |
| Decision Date | 2015-11-24 |
| Notice Date | 2017-02-27 |
| PMA | P130018 |
| Supplement | S |
| Product Code | EZY |
| Docket Number | 15M-4473 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UROMEDICA INC 1840 Berkshire Lane N plymouth, MN 55441 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |