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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceRESTYLANE L INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Q-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS056
Date Received01/10/2012
Decision Date08/30/2012
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 12M-0968
Notice Date 09/12/2012
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00797459
NCT00935272
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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