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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
Generic Nameimplant, dermal, for aesthetic use
ApplicantQ-Med AB
seminariegatan 21
uppsala S-752-7522
PMA NumberP140029
Supplement NumberS001
Date Received01/11/2017
Decision Date04/12/2017
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
Approval Order Statement  
Approval for the addition of a second dialysis equipment to complement the current vessel used in the bulk manufacturing process for Restylane Refyne and Restylane Defyne.