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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® (injectable poly-L Lactic acid)
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP030050
Supplement NumberS052
Date Received09/05/2024
Decision Date10/02/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to increase the sieving maximum batch size to 30kg for PLLA
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