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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 Gels
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS134
Date Received09/07/2022
Decision Date09/30/2022
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add a permanent transverse wall between cleanrooms 9:175 and 9:176 in manufacturing L3 for Restylane®, Restylane®-L, Restylane® Lyft with Lidocaine, Perlane® and Restylane® Silk production.
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