|
Device | VENTANA MMR RxDx Panel |
Generic Name | immunohistochemistry test, dna mismatch repair (mmr) protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems Inc (Roche Tissue Diagnostics) 1910 e. innovation park drive tucson, AZ 85755 |
PMA Number | P210001 |
Date Received | 01/22/2021 |
Decision Date | 08/17/2021 |
Product Code |
QNH |
Docket Number | 21M-0915 |
Notice Date | 08/25/2021 |
Advisory Committee |
Pathology |
Clinical Trials | NCT02715284
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 S004 S005 S006 |