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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/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.
 
DevicePATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Date Received12/13/1999
Decision Date11/28/2000
Product Code MVC 
Docket Number 00M-1661
Notice Date 12/12/2000
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S011 S010  S021 S022 S012 S013 S023 S018 S019 S020 S017 
S004 S001 S006 S007 S035 S036 S014 S027 S028 S029 S015 S030 
S034 S031 S032 S033 S024 S016 S002 S003 S005 S008 S041 S043 
S048 S047 S050 S056 S054 S057 S058 S059 S055 S038 S042 S040 
S039 S044 S046 S045 S052 S053 S051 S060 S025 S026 
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