PMA P210001S013

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S013
Product code: QNH
Decision date: 2024-12-18
Classification: Pathology
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: approval to include a companion diagnostic indication to identify adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, who are eligible for treatment with IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel, followed by IMFINZI® (durvalumab) as a single agent.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S013
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2024-12-18
Decision code: APPR
Date received: 2024-07-17
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval to include a companion diagnostic indication to identify adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, who are eligible for treatment with IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel, followed by IMFINZI® (durvalumab) as a single agent.