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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 NameZYDERM COLLAGEN IMPLANT (ZYDERM CI)
Classification Nameimplant, dermal, for aesthetic use
Generic Namedermal implants of collagen for aesthetic use
ApplicantCOLLAGEN CORP.
PMA NumberP800022
Supplement NumberS023
Date Received06/27/1991
Decision Date06/16/1995
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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