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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 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
Supplement NumberS009
Date Received12/06/2010
Decision Date12/09/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR: 1) A REVISION OF SCULPTRA AND SCULPTRA AESTHETIC LABELING TO INCLUDE INFORMATION CONCERNING A PRECLINICAL IMAGING STUDY COMPLETED AS CONDITION OF APPROVAL; AND 2) TO REVISE THE STORAGE CONDITIONS PRESENTED IN YOUR PRODUCT LABEL.
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