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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
Classification Nameimplant, dermal, for aesthetic use
Generic Namedermal implants of collagen for aesthetic use
ApplicantINAMED CORPORATION
PMA NumberP800022
Supplement NumberS050
Date Received05/16/2001
Decision Date03/11/2003
Product Code
LMH[ Registered Establishments with 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 Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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