RHA 2, RHA 3, RHA Dermal Fillers
FDA premarket approval P170002/S018 · decided 2021-08-13
Approval details
- PMA number
- P170002
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA 2, RHA 3, RHA Dermal Fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2021-07-16
- Decision date
- 2021-08-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- 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.
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