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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DevicePATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP990081
Date Received12/13/1999
Decision Date11/28/2000
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 
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