RHA® Redensity, RHA® 2, RHA® 3, RHA® 4
FDA premarket approval P170002/S037 · decided 2024-07-31
Approval details
- PMA number
- P170002
- Supplement
- S037
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA® Redensity, RHA® 2, RHA® 3, RHA® 4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-02-02
- Decision date
- 2024-07-31
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- approval of 1) Change of expression of lidocaine, impurity and total degradation products; 2) Transfering and consolidating of all testing of lidocaine and its degradation products to Teoxane site.
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