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 | 1988-06-21 |
Decision Date | 1988-07-18 |
PMA | P850053 |
Supplement | S001 |
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 |