- Device
- RHA 2, RHA 3, RHA 4 Dermal Fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S010
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-02-10
- Decision code
- APPR
- Date received
- 2020-07-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate analytical laboratory for the determination of residual 1,4-butanediol diglycidyl ether (BDDE) as part of batch release testing.