RHA® Redensity, RHA®2, RHA®3, RHA®4
FDA premarket approval P170002/S031 · decided 2023-06-12
Approval details
- PMA number
- P170002
- Supplement
- S031
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA® Redensity, RHA®2, RHA®3, RHA®4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2023-05-12
- Decision date
- 2023-06-12
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
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