PMA P170002S041

Device
RHA 2, RHA 3, RHA 4
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S041
Product code
LMH
Decision date
2026-04-07
Classification
General, Plastic Surgery
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for implementation of parametric release after terminal steam sterilization of the RHA® and RHA® Mepi families of dermal fillers.

Current openFDA PMA Record#

Device
RHA 2, RHA 3, RHA 4
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S041
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2026-04-07
Decision code
APPR
Date received
2024-07-19
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for implementation of parametric release after terminal steam sterilization of the RHA® and RHA® Mepi families of dermal fillers.