Approval for genvisc 850®. This device is indicated for or 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 | GENVISC 850 |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | ORTHOGENRX,INC |
| Date Received | 2014-04-16 |
| Decision Date | 2015-09-02 |
| Notice Date | 2015-10-15 |
| PMA | P140005 |
| Supplement | S |
| Product Code | MOZ |
| Docket Number | 15M-3258 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHOGENRX,INC 7044 Ely Road new Hope, PA 18938 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140005 | | Original Filing |
| S004 |
2020-05-08 |
Special (immediate Track) |
| S003 | | |
| S002 | | |
| S001 | | |
NIH GUDID Devices