RHA® Dynamic Volume, RHA®4
FDA premarket approval P170002/S048 · decided 2025-09-18
Approval details
- PMA number
- P170002
- Supplement
- S048
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA® Dynamic Volume, RHA®4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-12-02
- Decision date
- 2025-09-18
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for RHA®4 and RHA® Dynamic Volume for expanding the indications to include injection into the subcutaneous to supraperiosteal layers for cheek augmentation and/or correction of age-related midface contour deficiencies in patients aged 22 or older.
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