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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.
 
DeviceCOSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93117-5506
PMA NumberP800022
Supplement NumberS055
Date Received11/13/2006
Decision Date12/19/2006
Withdrawal Date 10/25/2011
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE GLUTARALDEHYDE CROSSLINKER CONCENTRATION.
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