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 suspension of postapproval study because company is discontinuing manufacture and distribution of device.
| Device | RELIANCE URINARY CONTROL INSERT & SIZING DEVICE |
| Generic Name | Transurethral Occlusion Insert, Urinary Incontinence-control, Female |
| Applicant | UROMED CORP. |
| Date Received | 1999-03-17 |
| Decision Date | 1999-04-01 |
| PMA | P960020 |
| Supplement | S001 |
| Product Code | OCK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UROMED CORP. 64 A St. needham, MA 02194 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960020 | Original Filing | |
| S001 | 1999-03-17 | Normal 180 Day Track |