RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi
FDA premarket approval P170002/S044 · decided 2024-10-18
Approval details
- PMA number
- P170002
- Supplement
- S044
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-09-19
- Decision date
- 2024-10-18
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for the implementation of a new inspection step to improve the visual control process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.