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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceFIBREL
Generic NameImplant, dermal, for aesthetic use
ApplicantMentor Corp.
201 Mentor Dr.
Santa Barbara, CA 93111
PMA NumberP850053
Supplement NumberS004
Date Received06/10/1991
Decision Date08/14/1991
Withdrawal Date02/28/2008
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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