PMA P200019S008

Device: VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S008
Product code: QNH
Decision date: 2023-11-08
Classification: Pathology
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: addition of an alternative supplier for dispenser component parts

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM
Applicant: Ventana Medical Systems
PMA number: P200019
Supplement: S008
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2023-11-08
Decision code: OK30
Date received: 2023-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternative supplier for dispenser component parts