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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCULPTRA & SCULPTRA Aesthetic
Generic Nameimplant, dermal, for aesthetic use
ApplicantQ-Med AB
seminariegatan 21
uppsala SE-75-752-
PMA NumberP030050
Supplement NumberS027
Date Received11/20/2017
Decision Date12/14/2017
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Installation of a new sieving process hopper for PLLA particles for Sculptra and Sculptra Aesthetic.
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