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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 Contour
Generic Nameimplant, dermal, for aesthetic use
ApplicantQ-Med AB
seminariegatan 21
uppsala S-752-7522
PMA NumberP140029
Supplement NumberS043
Date Received11/05/2021
Decision Date11/30/2021
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
Approval Order Statement  
Introduce new equipment on one of the manufacturing lines that will enable a new alternative bulk process.
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