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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
ApplicantVALEANT INTERNATIONAL BERMUDA
PMA NumberP030050
Supplement NumberS018
Date Received07/22/2013
Decision Date08/16/2013
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 
The following changes: 1) replacement of the gamma radiation source and requalification of sterilization at the dagneux france facility; 2) packaging modification for the raw material, including a new bag supplier and the introduction of a new bagging configuration; and 3) replacement of the gamma radiation source and requalification at the sablé france facility.
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