PMA P210001S001

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S001
Product code: QNH
Decision date: 2022-03-21
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
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 KEYTRUDA.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S001
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2022-03-21
Decision code: APPR
Date received: 2021-08-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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 KEYTRUDA.