VENTANA MMR RxDx Panel

FDA Premarket Approval P200019

Pre-market Approval Supplement Details

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.

DeviceVENTANA MMR RxDx Panel
Generic NameImmunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay
ApplicantVentana Medical Systems
Date Received2020-03-16
Decision Date2021-04-22
PMAP200019
SupplementS
Product CodeQNH 
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems 1910 East Innovation Park Drive tucson, AZ 85755

Supplemental Filings

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Supplement NumberDateSupplement Type
P200019Original Filing

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