PMA P240022

Device
Evolysse™ Smooth; Evolysse™ Form
Applicant
Symatese
Product code
LMH
Decision date
2026-02-27
Generic name
Implant, dermal, for aesthetic use
Approval order statement
a semi-automated finger grip assembly process

Current openFDA PMA Record

Device
Evolysse™ Smooth; Evolysse™ Form
Applicant
Symatese
PMA number
P240022
Supplement
S005
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2026-02-27
Decision code
OK30
Date received
2026-02-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a semi-automated finger grip assembly process

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