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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSCULPTRA AND SCULPTRA AESTHETIC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable poly-l-lactic acid
ApplicantSANOFI AVENTIS U.S. LLC
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 - instructions
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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