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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.
 
DeviceZYPLAST(R) COLLAGEN IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93117-5506
PMA NumberP800022
Supplement NumberS034
Date Received03/03/1992
Decision Date07/07/1992
Withdrawal Date 10/25/2011
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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