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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 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.
 
DevicePREVELLE SILK
Generic NameImplant, dermal, for aesthetic use
ApplicantGENZYME BIOSURGERY
55 CAMBRIDGE PARKWAY
CAMBRIDGE, MA 02142
PMA NumberP030032
Supplement NumberS007
Date Received07/25/2007
Decision Date02/26/2008
Withdrawal Date 02/10/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ADDITION OF PHOSPHATE BUFFERED SALINE (PBS) AND LIDOCAINE HYDROCHLORIDE (HCL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELLE SILK AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
Post-Approval StudyShow Report Schedule and Study Progress
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