Premarket Approval (PMA)

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.

• Device: EVOLYSSE® FORM and EVOLYSSE® SMOOTH
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Symatese; Zi Les Troques; Chaponost 69630
• PMA Number: P240022
• Supplement Number: S001
• Date Received: 04/30/2025
• Decision Date: 09/03/2025
• Product Code: LMH
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
approval of the protocol for the post-approval study (PAS).