RHA 3 Mepi
FDA premarket approval P170002/S043 · decided 2025-01-17
Approval details
- PMA number
- P170002
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA 3 Mepi
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-08-07
- Decision date
- 2025-01-17
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for expanding the labeling of RHA® 3 Mepi to add a new indication for injection in the vermillion body, vermillion border and oral commissures to achieve lip augmentation and lip fullness in subjects aged 22 or older.
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