PMA P170002S019

Device
RHA®4 Dermal Filler
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S019
Product code
LMH
Decision date
2021-10-22
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of RHA®4 Dermal Filler.

Current openFDA PMA Record#

Device
RHA®4 Dermal Filler
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S019
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2021-10-22
Decision code
APPR
Date received
2021-07-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of RHA®4 Dermal Filler.