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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
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