PMA P990081S053

Device: PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Applicant: Ventana Medical Systems, Inc.
PMA number: P990081
Supplement: S053
Product code: MVC
Decision date: 2024-01-26
Classification: Pathology
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

Current openFDA PMA Record#

Device: PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Applicant: Ventana Medical Systems, Inc.
PMA number: P990081
Supplement: S053
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Decision date: 2024-01-26
Decision code: APPR
Date received: 2023-10-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).