Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
• Classification Name: system, test, her-2/neu, ihc
• Generic Name: system, test, her-2/neu, ihc
• Applicant: VENTANA MEDICAL SYSTEMS, INC.; 1910 e. innovation park dr.; tucson, AZ 85755
• PMA Number: P990081
• Date Received: 12/13/1999
• Decision Date: 11/28/2000
• Product Code: MVC [ Registered Establishments with MVC ]
• Docket Number: 00M-1661
• Notice Date: 12/12/2000
• Advisory Committee: Pathology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement 
APPROVAL FOR THE PATHWAY(TM) HER 2 (CLONE CB11). THE DEVICE IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB-2 ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN(R) TREATMENT IS BEING CONSIDERED.

Approval Order

Approval Order

Summary

Summary of Safety and Effectiveness

Labeling

Labeling

• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 ; S011 S012 S013 S014 S015 S016 S017 S018 S019 ; S020 S021 S022 S023 S024 S025 S026 S027 S028 ; S029 S030 S031 S032 S033 S034 S035 S036 S038 ; S039 S040