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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 NumberS015
Date Received11/01/1988
Decision Date11/22/1988
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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