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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 (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID)
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable poly-l-lactic acid
ApplicantSANOFI AVENTIS U.S. LLC
PMA NumberP030050
Supplement NumberS010
Date Received05/16/2011
Decision Date06/14/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the location of the design control center for sculptra and sculptra aethetic from sanofi aventis u. S. Llc to anagni italy.
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