RHA® Redensity
FDA premarket approval P170002/S012 · decided 2021-12-22
Approval details
- PMA number
- P170002
- Supplement
- S012
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHA® Redensity
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2021-01-08
- Decision date
- 2021-12-22
- Days to decision
- 348 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for the RHA® Redensity is indicated for injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids, in adults aged 22 years or older.
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