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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 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93117-5506
PMA NumberP800022
Supplement NumberS050
Date Received05/16/2001
Decision Date03/11/2003
Withdrawal Date 10/25/2011
Product Code LMH 
Docket Number 03M-0114
Notice Date 03/28/2003
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN. THE INDICATIONS FOR USE ARE AS FOLLOWS: COSMODERM 1 HUMAN-BASED COLLAGEN AND COSMODERM 2 HUMAN-BASED COLLAGEN ARE INJECTED INTO THE SUPERFICIAL PAPILLARY DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS, AND COSMOPLAST HUMAN-BASED COLLAGEN IS INJECTED INTO THE MID TO DEEP DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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