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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.
 
DeviceRESTYLANE L INJECTABLE GEL
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS056
Date Received01/10/2012
Decision Date08/30/2012
Product Code LMH 
Docket Number 12M-0968
Notice Date 09/12/2012
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00797459
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR RESTYLANE L INJECTABLE GEL. THIS DEVICE IS INDICATED FOR: 1) MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND 2) SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION IN PATIENTS OVER THE AGE OF 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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