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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
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Q-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP030050
Supplement NumberS002
Date Received07/28/2006
Decision Date07/28/2009
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 09M-0370
Notice Date 08/04/2009
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR SCULPTRA AESTHETIC. THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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