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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 NumberS051
Date Received01/17/2024
Decision Date07/17/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for (1) a new plastic syringe and new plunger, new plunger rod, new finger grip, and new secondary packaging for Restylane Contour approved under PMA P140029; (2) implementation of these changes on a new manufacturing line (L3) for automated assembly and packaging; and (3) modification of the secondary packaging and labelling to fit the new syringe and packaging line.
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