RHA®3 dermal filler
FDA premarket approval P170002/S030 · decided 2023-10-27
Approval details
- PMA number
- P170002
- Supplement
- S030
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RHA®3 dermal filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2023-05-01
- Decision date
- 2023-10-27
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for RHA®3 for expanding the indications to include injection in the vermillion body, vermillion border and oral commissures to achieve lip augmentation and lip fullness in adults aged 22 years or older. RHA®3 is also indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.