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 for labeling modifications.
| 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 | 2012-12-26 |
| Decision Date | 2013-03-21 |
| PMA | P990002 |
| Supplement | S002 |
| Product Code | OCK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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) |