PMA P170002S020
- Device
- RHA 2, RHA 3, RHA 4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S020
- Product code
- LMH
- Decision date
- 2022-02-24
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Removal of in-process control (IPC) tests for pH at dialysis and rheology at filling during the manufacturing of RHA 2, RHA 3, and RHA 4
Current openFDA PMA Record#
- Device
- RHA 2, RHA 3, RHA 4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S020
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-02-24
- Decision code
- OK30
- Date received
- 2022-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of in-process control (IPC) tests for pH at dialysis and rheology at filling during the manufacturing of RHA 2, RHA 3, and RHA 4