Approval for revision of the instructions for administration of genvisc 850 to help prevent any leakage of the product during administration.
| Device | GenVisc 850 |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | ORTHOGENRX,INC |
| Date Received | 2020-05-08 |
| Decision Date | 2020-06-07 |
| PMA | P140005 |
| Supplement | S004 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHOGENRX,INC 2005 South Easton Road suite 207 doylestown, PA 18901 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140005 | | Original Filing |
| S004 |
2020-05-08 |
Special (immediate Track) |
| S003 | | |
| S002 | | |
| S001 | | |
NIH GUDID Devices