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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 ZYPLAST COLLAGEN IMPLANT COSMODERM COSMOPLAST HUMAN COLLAGEN IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93117-5506
PMA NumberP800022
Supplement NumberS054
Date Received02/24/2006
Decision Date03/22/2006
Withdrawal Date 10/25/2011
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGE OF COMPONENT SUPPLIER.
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