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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, PERLANE L, RESTYLANE SILK INJECTABLE GELS
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS076
Date Received07/02/2014
Decision Date12/08/2014
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PROPOSED INTRODUCTION OF AN ALTERNATE BULK MANUFACTURING ROOMIN THE MANUFACTURING PROCESS USED IN FACTORY 2 (F2) AT THE QMED FACILITY IN UPPSALA, SWEDEN.
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