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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
ApplicantQ-MED AB
PMA NumberP030050
Supplement NumberS021
Date Received04/01/2014
Decision Date04/29/2014
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 
Replacement of the motor for a hopper and subsequent requalification of that hopper at the firm¿s manufacturing facility.
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