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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.
 
DeviceSCULPTRA AND SCULPTRA AESTHETIC
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP030050
Supplement NumberS018
Date Received07/22/2013
Decision Date08/16/2013
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
Approval Order Statement  
THE FOLLOWING CHANGES: 1) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION OF STERILIZATION AT THE DAGNEUX FRANCE FACILITY; 2) PACKAGING MODIFICATION FOR THE RAW MATERIAL, INCLUDING A NEW BAG SUPPLIER AND THE INTRODUCTION OF A NEW BAGGING CONFIGURATION; AND 3) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION AT THE SABLÉ FRANCE FACILITY.
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