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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/RESTYLANE-L/ PERLANE/ PERLANE-L , RESTYLANE SILK(INJECTABLE GELS)
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-75-752-
PMA NumberP040024
Supplement NumberS079
Date Received02/12/2015
Decision Date01/26/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A NEW SYRINGE CONTAINER CLOSURE SYSTEM FOR RESTYLANE®, RESTYLANE-L®, PERLANE®, PERLANE-L® AND RESTYLANE® SILK.
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