Premarket Approval (PMA)

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.

• Device: COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Allergan; 71 S. Los Carneros Rd.; Goleta, CA 93117-5506
• PMA Number: P800022
• Supplement Number: S050
• Date Received: 05/16/2001
• Decision Date: 03/11/2003
• Withdrawal Date: 10/25/2011
• Product Code: LMH
• Docket Number: 03M-0114
• Notice Date: 03/28/2003
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling