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 add the precaution "avoid heat" to the labeling. The device, as modified, will be marketed under the trade name femsoft(r) insert and 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 | 2000-12-14 |
| Decision Date | 2000-12-28 |
| PMA | P990002 |
| Supplement | S001 |
| Product Code | OCK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHESTER MEDICAL CORP. one Rochester Medical Dr. stewartville, MN 55976 |
| 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) |