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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 Kysse
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala S-752 28
PMA NumberP140029
Supplement NumberS048
Date Received03/13/2023
Decision Date04/12/2023
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 Kysse as a result of postmarket surveillance data.
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