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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
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP040024
Supplement NumberS096
Date Received02/16/2017
Decision Date10/11/2017
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02703948
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for use of a small bore, blunt tip cannula with Restylane Silk for submucosal implantation for lip augmentation in patients over the age of 21.
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