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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 / Perlane / Restylane-L / Restylane-Lyft(formerly Perlane-L) Restylane Silk.
Generic Nameimplant, dermal, for aesthetic use
ApplicantQ-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS100
Date Received10/24/2017
Decision Date11/17/2017
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  
Change in the quality specification of Lidocaine Hydrochloride to align it with the updated USP monograph and the introduction of skip testing for some of the in-house tests already performed by the manufacturer of Lidocaine Hydrochloride.
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