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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
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
SEMINARIEGATAN 21
UPPSALA SE-75-752-
PMA NumberP030050
Date Received12/01/2003
Decision Date08/03/2004
Product Code LMH 
Docket Number 04M-0350
Notice Date 08/09/2004
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S019 S016 S017  S001 S020 S009 S010 S011 S038 S039 S040 
S043 S042 S035 S036 S037 S022 S004 S008 S002 S025 S013 S014 
S021 S015 S018 S005 S006 S003 S007 S024 S026 S030 S031 S033 
S034 S028 S027 S029 S032 S044 S045 S046 S047 
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