RHA 2, RHA 3, RHA 4
FDA premarket approval P170002/S022 · decided 2023-05-12
Approval details
- PMA number
- P170002
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA 2, RHA 3, RHA 4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2022-04-14
- Decision date
- 2023-05-12
- Days to decision
- 393 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval to update the labeling to allow RHA®2, RHA®3 and RHA®4 to be injected with a blunt tip cannula (25G x 2) as well as a needle.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.