RHA 2, RHA 3, RHA 4 dermal fillers
FDA premarket approval P170002/S014 · decided 2021-04-15
Approval details
- PMA number
- P170002
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA 2, RHA 3, RHA 4 dermal fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2021-03-16
- Decision date
- 2021-04-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for updated labeling to include adverse events from post market surveillance for RHA 2, RHA 3, and RHA 4
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