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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 AND PERLANE L INJECTABLE GELS
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS039
Date Received04/16/2009
Decision Date01/29/2010
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00797459
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO RESTYLANE AND PERLANE. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RESTYLANE-L AND PERLANE-L AND ISINDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND FOR IMPLANTATION INTO THE DEEP DERMIS TOSUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH ASNASOLABIAL FOLDS, RESPECTIVELY.
Approval OrderApproval Order
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