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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 NamePREVELLE SILK
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylaform
ApplicantGENZYME CORP.
PMA NumberP030032
Supplement NumberS013
Date Received09/09/2011
Decision Date10/07/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a raw material identification system and an automated filter integrity test instrument.
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