TRILURON
FDA premarket approval P180040 · decided 2019-03-26
Approval details
- PMA number
- P180040
- Trade name
- TRILURON
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici S.P.A.
- Date received
- 2018-09-27
- Decision date
- 2019-03-26
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- Approval for TRILURON. The device is indicated for use in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
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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 |