RHA 2, RHA 3, and RHA 4 Dermal Fillers
FDA premarket approval P170002/S005 · decided 2019-10-29
Approval details
- PMA number
- P170002
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHA 2, RHA 3, and RHA 4 Dermal Fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2019-06-18
- Decision date
- 2019-10-29
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for extension of products shelf-life from 17 months to 36 months.
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