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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.
 
DeviceRestlyane® Refyne Injectable Gel
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala S-752 28
PMA NumberP140029
Supplement NumberS047
Date Received11/21/2022
Decision Date12/23/2022
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate 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 revisions to the clinician labeling and patient labeling of Restylane® Refyne Injectable Gel as a result of postmarket surveillance data.
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