PMA P210001S002

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Product code: QNH
Decision date: 2022-06-16
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: Approval for the VENTANA MMR RxDx Panel as a companion diagnostic for identifying MMR proficient (pMMR) patients with endometrial cancer for treatment with KEYTRUDA in combination with LENVIMA.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S002
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2022-06-16
Decision code: APPR
Date received: 2021-12-20
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 companion diagnostic for identifying MMR proficient (pMMR) patients with endometrial cancer for treatment with KEYTRUDA in combination with LENVIMA.