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.
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.
| 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. |
| Date Received | 1999-12-13 |
| Decision Date | 2000-11-28 |
| Notice Date | 2000-12-12 |
| PMA | P990081 |
| Supplement | S |
| Product Code | MVC |
| Docket Number | 00M-1661 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990081 | Original Filing | |
| S050 | 2022-10-14 | 30-day Notice |
| S049 | ||
| S048 | 2022-07-12 | 30-day Notice |
| S047 | ||
| S046 | 2022-02-16 | Special (immediate Track) |
| S045 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S044 | 2021-02-22 | Real-time Process |
| S043 | 2020-08-26 | Real-time Process |
| S042 | 2020-01-13 | Real-time Process |
| S041 | 2019-08-22 | Real-time Process |
| S040 | 2019-04-09 | 30-day Notice |
| S039 | 2019-02-13 | Normal 180 Day Track |
| S038 | 2018-06-18 | Real-time Process |
| S037 | ||
| S036 | ||
| S035 | 2016-11-15 | Normal 180 Day Track |
| S034 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S033 | 2015-08-26 | 30-day Notice |
| S032 | 2015-08-14 | 30-day Notice |
| S031 | 2014-10-27 | 30-day Notice |
| S030 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S029 | 2014-02-14 | Normal 180 Day Track |
| S028 | 2014-02-06 | Real-time Process |
| S027 | 2014-01-22 | Real-time Process |
| S026 | 2014-01-06 | 30-day Notice |
| S025 | 2013-12-27 | 30-day Notice |
| S024 | 2013-11-12 | 30-day Notice |
| S023 | 2013-10-28 | 30-day Notice |
| S022 | 2013-08-30 | 30-day Notice |
| S021 | 2013-07-30 | 30-day Notice |
| S020 | 2013-05-07 | 135 Review Track For 30-day Notice |
| S019 | 2013-05-06 | Real-time Process |
| S018 | 2013-04-17 | 30-day Notice |
| S017 | 2013-03-12 | Real-time Process |
| S016 | 2013-03-04 | 30-day Notice |
| S015 | 2013-01-14 | Real-time Process |
| S014 | 2012-08-31 | Real-time Process |
| S013 | 2012-07-27 | 30-day Notice |
| S012 | 2012-07-25 | Real-time Process |
| S011 | 2011-05-23 | Normal 180 Day Track |
| S010 | 2011-01-03 | Normal 180 Day Track |
| S009 | ||
| S008 | 2010-10-21 | Special (immediate Track) |
| S007 | 2007-11-19 | 30-day Notice |
| S006 | 2007-06-27 | 30-day Notice |
| S005 | 2007-03-02 | Special (immediate Track) |
| S004 | 2006-08-28 | 30-day Notice |
| S003 | 2006-05-04 | Normal 180 Day Track |
| S002 | 2005-09-06 | Real-time Process |
| S001 | 2002-08-20 | Normal 180 Day Track |