TRILURON® (sodium hyaluronate)
FDA premarket approval P180040/S004 · decided 2023-01-19
Approval details
- PMA number
- P180040
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRILURON® (sodium hyaluronate)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 2022-12-23
- Decision date
- 2023-01-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- Change to the manufacturing procedure, including methods for filtration and washes for the sodium hyaluronate bulk powder.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HyaloGYN Vaginal Moisturizing Suppositories (K191052) | Fidia Farmaceutici S.P.A. | 2020-01-09 |
| HyaloGYN Vaginal Hydrating Gel (K150883) | Fidia Farmaceutici S.P.A. | 2015-09-01 |
| HYALO GYN (K094039) | Fidia Farmaceutici S.P.A. | 2010-05-07 |