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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 AESTHETIC
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP030050
Supplement NumberS014
Date Received12/20/2012
Decision Date05/28/2013
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REVISION OF A PRECAUTION STATEMENT IN YOUR PRODUCT LABEL TO STATE: SCULPTRA AESTHETIC SHOULD ONLY BE USED BY A HEALTHCARE PRACTITIONER TRAINED TO CORRECT SHALLOW TO DEEP NASOLABIAL CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES, IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE, AFTER THE HEALTHCARE PRACTITIONER IS FULLY FAMILIAR WITH THE PRODUCT, WAS, PRODUCT EDUCATIONAL MATERIALS, AND THE ENTIRE PACKAGE INSERT AND PATIENT LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCULPTRA AESTHETIC AND IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLE REGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
Post-Approval StudyShow Report Schedule and Study Progress
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