RHA® Redensity, RHA® Redensity Mepi
FDA premarket approval P170002/S045 · decided 2024-10-18
Approval details
- PMA number
- P170002
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RHA® Redensity, RHA® Redensity Mepi
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-09-18
- Decision date
- 2024-10-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P170002/S034.
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