PMA P170002S021

Device
RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S021
Product code
LMH
Decision date
2022-06-14
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for design changes of the plunger and finger grip of the syringe.

Current openFDA PMA Record#

Device
RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S021
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2022-06-14
Decision code
APPR
Date received
2022-03-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design changes of the plunger and finger grip of the syringe.