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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFIBREL
Classification Nameimplant, dermal, for aesthetic use
Generic Namegelatin matrix implant
ApplicantMENTOR CORP.
PMA NumberP850053
Supplement NumberS002
Date Received07/18/1988
Decision Date06/27/1990
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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