PMA P170002S018
- Device
- RHA 2, RHA 3, RHA Dermal Fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S018
- Product code
- LMH
- Decision date
- 2021-08-13
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of a new cleanroom and extension of maximum holding times at two points during the manufacturing of RHA 2, RHA 3, and RHA 4 gels.
Current openFDA PMA Record#
- Device
- RHA 2, RHA 3, RHA Dermal Fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S018
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-08-13
- Decision code
- OK30
- Date received
- 2021-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new cleanroom and extension of maximum holding times at two points during the manufacturing of RHA 2, RHA 3, and RHA 4 gels.