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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 NameZYDERM ZYPLAST COLLAGEN IMPLANT COSMODERM COSMOPLAST HUMAN COLLAGEN IMPLANT
Classification Nameimplant, dermal, for aesthetic use
Generic Namedermal implants of collagen for aesthetic use
ApplicantALLERGAN
PMA NumberP800022
Supplement NumberS054
Date Received02/24/2006
Decision Date03/22/2006
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change of component supplier.
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