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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 and Sculptra Aesthetic
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala SE-752-28
PMA NumberP030050
Supplement NumberS034
Date Received11/27/2020
Decision Date11/23/2021
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03780244
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in reconstitution and injection procedure for Sculptra Aesthetic, combining the physician labeling for Sculptra and Sculptra Aesthetic, marketing Sculptra and Sculptra Aesthetic under the single trade name, Sculptra, and new secondary packaging
Post-Approval StudyShow Report Schedule and Study Progress
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