PMA P200019S004

Device: VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S004
Product code: QNH
Decision date: 2022-07-21
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S004
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2022-07-21
Decision code: APPR
Date received: 2022-02-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.