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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-752-7522
PMA NumberP140029
Supplement NumberS032
Date Received09/18/2020
Decision Date06/28/2021
Product Code LMH 
Docket Number 21M-0676
Notice Date 07/08/2021
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03700047
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Restylane Contour is indicated for use in cheek augmentation and correction of midface contour deficiencies in patients over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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