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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameFIBREL
Classification Nameimplant, dermal, for aesthetic use
Generic Namegelatin matrix implant
PMA NumberP850053
Date Received07/31/1985
Decision Date02/26/1988
Withdrawal Date 02/28/2008
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 88M-0094
Notice Date 05/03/1988
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004