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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSCULPTRA AND SCULPTRA 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
Date Received12/01/2003
Decision Date08/03/2004
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 04M-0350
Notice Date 08/09/2004
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR SCULPTRA. THE DEVICE IS INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S024 S025 S026 
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