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.
The device is indicated for the management of stress urinary incontinence in adult females.
| Device | FEMSOFT URETHRAL INSERT |
| Classification Name | Transurethral Occlusion Insert, Urinary Incontinence-control, Female |
| Generic Name | Transurethral Occlusion Insert, Urinary Incontinence-control, Female |
| Applicant | ROCHESTER MEDICAL CORP. |
| Date Received | 1999-01-19 |
| Decision Date | 1999-09-30 |
| Notice Date | 1999-10-15 |
| PMA | P990002 |
| Supplement | S |
| Product Code | OCK |
| Docket Number | 99M-4330 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHESTER MEDICAL CORP. one Rochester Medical Dr. stewartville, MN 55976 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990002 | Original Filing | |
| S002 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S001 | 2000-12-14 | Special (immediate Track) |