Approval for the ventana mmr rxdx pavel as a cdx for identifying patients with endometrial cancer 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 |
| Date Received | 2020-03-16 |
| Decision Date | 2021-04-22 |
| PMA | P200019 |
| Supplement | S |
| Product Code | QNH |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems 1910 East Innovation Park Drive tucson, AZ 85755 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200019 | Original Filing | |
| S006 | 2022-10-14 | 30-day Notice |
| S005 | 2022-07-12 | 30-day Notice |
| S004 | 2022-02-16 | Special (immediate Track) |
| S003 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 |