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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.
 
DeviceEvolysse Injectable Hyaluronic Acid
Generic NameImplant, dermal, for aesthetic use
ApplicantSymatese
Zi Les Troques
Chaponost 69630
PMA NumberP240022
Supplement NumberS004
Date Received12/05/2025
Decision Date12/19/2025
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the syringe plunger rod for the Evolysse injectable hyaluronic acid gels approved under P240022
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