Approval for trivisc. The device is indicated for 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 | TRIVISC |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | ORTHOGENRX,INC |
| Date Received | 2016-12-23 |
| Decision Date | 2017-11-13 |
| Notice Date | 2017-11-21 |
| PMA | P160057 |
| Supplement | S |
| Product Code | MOZ |
| Docket Number | 17M-6525 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHOGENRX,INC 3805 Old Easton Road doylestown, PA 18902-8400 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160057 | | Original Filing |
| S001 |
2020-05-08 |
Special (immediate Track) |
NIH GUDID Devices