PMA P170002S005

Device
RHA 2, RHA 3, and RHA 4 Dermal Fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S005
Product code
LMH
Decision date
2019-10-29
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for extension of products’ shelf-life from 17 months to 36 months.

Current openFDA PMA Record#

Device
RHA 2, RHA 3, and RHA 4 Dermal Fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S005
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-10-29
Decision code
APPR
Date received
2019-06-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for extension of products’ shelf-life from 17 months to 36 months.