Note: 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. |
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Device | FIBREL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MENTOR CORP. 201 MENTOR DRIVE SANTA BARBARA, CA 93111 |
PMA Number | P850053 |
Supplement Number | S003 |
Date Received | 01/11/1989 |
Decision Date | 02/09/1989 |
Withdrawal Date
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02/28/2008 |
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 Granted? | No |
Combination Product | No |
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