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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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 
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