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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 Injectable Gel
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS132
Date Received09/06/2022
Decision Date12/20/2022
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 the addition of lidocaine hydrochloride from a new manufacturing site of the lidocaine hydrochloride supplier.
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