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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.
 
DeviceZYDERM COLLAGEN IMPLANT (ZYDERM CI)
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93117-5506
PMA NumberP800022
Supplement NumberS028
Date Received10/16/1991
Decision Date01/08/1992
Withdrawal Date 10/25/2011
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
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