RHA 3
FDA premarket approval P170002/S036 · decided 2024-02-29
Approval details
- PMA number
- P170002
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RHA 3
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-01-29
- Decision date
- 2024-02-29
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval of the protocol for the post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order for P170002/S030.
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