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).
| Device | TRILURON |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Fidia Pharma USA S.p.A. |
| Date Received | 2018-09-27 |
| Decision Date | 2019-03-26 |
| PMA | P180040 |
| Supplement | S |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Fidia Pharma USA S.p.A. via Ponte Della Fabbrica 3/a abano Terme 35031 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180040 | Original Filing | |
| S004 | 2022-12-23 | 30-day Notice |
| S003 | 2022-09-08 | 30-day Notice |
| S002 | 2022-07-11 | 30-day Notice |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| M71389122087901SAM1 | P180040 | 000 |
| M71389122087901A1 | P180040 | 000 |