RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers
FDA premarket approval P170002/S021 · decided 2022-06-14
Approval details
- PMA number
- P170002
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2022-03-17
- Decision date
- 2022-06-14
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for design changes of the plunger and finger grip of the syringe.
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