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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® Contour
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala S-752 28
PMA NumberP140029
Supplement NumberS057
Date Received04/16/2026
Decision Date05/15/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the post-approval study protocol to evaluate the safety of re-treatment with Restylane Contour in the treatment of temple hollowing
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