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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, SCULPTRA AESTHETIC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable poly-l-lactic acid
ApplicantVALEANT INTERNATIONAL (BARBADOS) SRL
PMA NumberP030050
Supplement NumberS013
Date Received12/18/2012
Decision Date01/16/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Does not qualify as a supp. - changes submitted in next annual report.
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