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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™ Smooth; Evolysse™ Form
Generic NameImplant, dermal, for aesthetic use
ApplicantSymatese
Zi Les Troques
Chaponost 69630
PMA NumberP240022
Supplement NumberS005
Date Received02/05/2026
Decision Date02/27/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a semi-automated finger grip assembly process
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