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.
| Device | FIBREL |
| Generic Name | Implant, Dermal, For Aesthetic Use |
| Applicant | MENTOR CORP. |
| Date Received | 1991-06-10 |
| Decision Date | 1991-08-14 |
| PMA | P850053 |
| Supplement | S004 |
| Product Code | LMH |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENTOR CORP. 201 Mentor Drive santa Barbara, CA 93111 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850053 | Original Filing | |
| S004 | 1991-06-10 | Normal 180 Day Track |
| S003 | 1989-01-11 | Normal 180 Day Track |
| S002 | 1988-07-18 | Normal 180 Day Track |
| S001 | 1988-06-21 | Normal 180 Day Track |