PMA P210001S008

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S008
Product code: QNH
Decision date: 2023-05-26
Classification: Pathology
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: Approval of PAS that was submitted to comply with the condition of approval #1 which required providing data to support the analytical sensitivity of the VENTANA MMR RxDx Panel for the solid tumor indication.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S008
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2023-05-26
Decision code: APPR
Date received: 2022-11-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval of PAS that was submitted to comply with the condition of approval #1 which required providing data to support the analytical sensitivity of the VENTANA MMR RxDx Panel for the solid tumor indication.