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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 NumberS128
Date Received11/15/2021
Decision Date12/09/2021
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane, Restylane-L, Restylane Lyft with Lidocaine, Perlane, and Restylane Silk.
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