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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.
 
DeviceHYLAFORM PLUS (HYLAN B GEL)
Generic NameImplant, dermal, for aesthetic use
ApplicantGENZYME BIOSURGERY
55 CAMBRIDGE PARKWAY
CAMBRIDGE, MA 02142
PMA NumberP030032
Supplement NumberS001
Date Received06/22/2004
Decision Date10/13/2004
Withdrawal Date 02/10/2016
Product Code LMH 
Docket Number 04M-0467
Notice Date 10/27/2004
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HYLAFORM PLUS. THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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