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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 Lyft with Lidocaine Cannula Injection
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS101
Date Received04/20/2018
Decision Date11/02/2018
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03160716
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of a small bore, blunt tip cannula with Restylane Lyft with Lidocaine for cheek augmentation and the correction of age related midface contour deficiencies in patients over the age of 21.
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