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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 Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala S-752 28
PMA NumberP140029
Supplement NumberS031
Date Received09/14/2020
Decision Date12/04/2020
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of changes to the Line 3 cleanrooms 9:169, 9:170, 9:177 and 9:190 in Facility 2, Building 9 at Q-Med ABs site located at Seminariegatan 21, SE-752 58 Uppsala, Sweden, used for the manufacturing of Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.
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