RHA®4 Dermal Filler
FDA premarket approval P170002/S019 · decided 2021-10-22
Approval details
- PMA number
- P170002
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHA®4 Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2021-07-26
- Decision date
- 2021-10-22
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of RHA®4 Dermal Filler.
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