RHA 2, RHA 3, RHA 4 Dermal Fillers
FDA premarket approval P170002/S010 · decided 2021-02-10
Approval details
- PMA number
- P170002
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA 2, RHA 3, RHA 4 Dermal Fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2020-07-20
- Decision date
- 2021-02-10
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for an alternate analytical laboratory for the determination of residual 1,4-butanediol diglycidyl ether (BDDE) as part of batch release testing.
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