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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
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP030050
Supplement NumberS040
Date Received12/06/2022
Decision Date06/02/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02425943
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated labeling to include 1) results from the 5-Year Post Approval Study; 2) device-specific use training program information; and 3) information on delayed-onset inflammation at the site of dermal filler injection following viral or bacterial illnesses or infections, vaccinations, or dental procedures.
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