PMA P170002S059
- Device
- RHA 2, RHA 3, RHA 4
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S059
- Product code
- LMH
- Decision date
- 2026-08-31
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for an alternative qualified laboratory for Biological Indicator release testing as part of receiving inspection
Current openFDA PMA Record#
- Device
- RHA 2, RHA 3, RHA 4
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S059
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-08-31
- Decision code
- OK30
- Date received
- 2026-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternative qualified laboratory for Biological Indicator release testing as part of receiving inspection