Approval for the ventana mmr rxdx panel as a cdx for identifying patients with solid tumors with dmmr status who may benefit from treatment with jemperli.
| Device | VENTANA MMR RxDx Panel |
| Generic Name | Immunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay |
| Applicant | Ventana Medical Systems Inc (Roche Tissue Diagnostics) |
| Date Received | 2021-01-22 |
| Decision Date | 2021-08-17 |
| PMA | P210001 |
| Supplement | S |
| Product Code | QNH |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems Inc (Roche Tissue Diagnostics) 1910 E. Innovation Park Drive tucson, AZ 85755 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210001 | Original Filing | |
| S007 | 2022-10-14 | 30-day Notice |
| S006 | 2022-07-12 | 30-day Notice |
| S005 | 2022-04-28 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | ||
| S002 | ||
| S001 | 2021-08-18 | Normal 180 Day Track |