PMA P170002S002

Device
RHA 2, RHA 3, and RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S002
Product code
LMH
Decision date
2019-03-22
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Automation of the degassing process.

Current openFDA PMA Record#

Device
RHA 2, RHA 3, and RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S002
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-03-22
Decision code
OK30
Date received
2019-02-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Automation of the degassing process.