RHA Redensity Mepi; RHA2 Mepi; RHA3 Mepi; RHA4 Mepi
FDA premarket approval P170002/S049 · decided 2025-04-22
Approval details
- PMA number
- P170002
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA Redensity Mepi; RHA2 Mepi; RHA3 Mepi; RHA4 Mepi
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2025-03-28
- Decision date
- 2025-04-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- to use in-house testing protocols for RHA Mepi dermal fillers
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