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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 AND COSMOPLAST HUMAN-BASED COLLAGEN
Classification Nameimplant, dermal, for aesthetic use
Generic Namedermal implants of collagen for aesthetic use
ApplicantINAMED CORPORATION
PMA NumberP800022
Supplement NumberS052
Date Received11/13/2003
Decision Date05/11/2004
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new raw material supplier for the human collagen component of cosmoderm and cosmoplast (i. E. , immucor/gamma biologicals of houston, texas).
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