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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 (INJECTABLE POLY-L-LACTIC ACID)
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP030050
Supplement NumberS017
Date Received04/05/2013
Decision Date10/10/2014
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00360932
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN PRODUCT LABELING TO DESCRIBE THE RESULTS OF A POSTAPPROVAL STUDY IN PATIENTS WITH HIV ASSOCIATED LIPOATROPHY.
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