VENTANA MMR RxDx Panel

FDA Premarket Approval P210001

Pre-market Approval Supplement Details

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.

DeviceVENTANA MMR RxDx Panel
Generic NameImmunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay
ApplicantVentana Medical Systems Inc (Roche Tissue Diagnostics)
Date Received2021-01-22
Decision Date2021-08-17
PMAP210001
SupplementS
Product CodeQNH 
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems Inc (Roche Tissue Diagnostics) 1910 E. Innovation Park Drive tucson, AZ 85755

Supplemental Filings

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement NumberDateSupplement Type
P210001Original Filing

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.