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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® FORM
Generic NameImplant, dermal, for aesthetic use
ApplicantSymatese
Zi Les Troques
Chaponost 69630
PMA NumberP240022
Supplement NumberS003
Date Received11/21/2025
Decision Date12/18/2025
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the Informed Consent Form used in the Post-Approval Study.
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