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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 INJECTABLE GELS
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP040024
Supplement NumberS035
Date Received02/09/2009
Decision Date03/05/2009
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES AS FOLLOWS: 1) ADD A NEW RAW MATERIAL SUPPLIER; 2) CHANGE THE SITE FOR RAW MATERIAL QUALITY ASSURANCE TESTING TO Q-MED AB; 3) ADD A HEAVY METALS TEST FOR RAW MATERIALS; AND 4) MODIFY A TEST METHOD FOR THE QUALITY CONTROL OF THE FINISHED PRODUCT.
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