RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
FDA premarket approval P170002/S026 · decided 2023-10-13
Approval details
- PMA number
- P170002
- Supplement
- S026
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2023-02-15
- Decision date
- 2023-10-13
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval of RHA® Redensity Mepi 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. Approval of RHA®2 Mepi, RHA@3 Mepi 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. Approval of RHA@4 Mepi for injection into the deep dermis to superficial subcutaneous
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.