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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 SILK SPHAL
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS072
Date Received10/21/2013
Decision Date06/13/2014
Product Code LMH 
Docket Number 14M-0872
Notice Date 06/30/2014
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01591369
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR RESTYLANE SILK. THIS DEVICE IS INDICATED FOR SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION AND DERMAL IMPLANTATION FOR CORRECTION OF PERIORAL RHYTIDS IN PATIENTS OVER THE AGE OF 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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