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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, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS073
Date Received05/01/2014
Decision Date07/01/2015
Product Code LMH 
Docket Number 15M-2634
Notice Date 07/27/2015
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01565915
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR RESTYLANE LYFT WITH LIDOCAINE. THIS DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS; AND FOR SUBCUTANEOUS TO SUPRAPERIOSTEAL IMPLANTATION FOR CHEEK AUGMENTATION AND CORRECTION OF AGE-RELATED MIDFACE CONTOUR DEFICIENCIES IN PATIENTS OVER THE AGE OF 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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