This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of labeling changes for the pathway her-2/neu (clone cd11) in the "intended use" section, addition of an "optional equipment not provided" section and changes to the "principles and procedures" section to reflect the addition of tripath imaging vias instrument to be used in conjunction with the ventana pathway her 2 assay as an optional accessory. The device, as modified, will be marketed under the same trade name patyhway her-2/neu (clone cd11) and is indicated: ventana medical systems, inc. 's (ventana) pathway her 2 (clone cd11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbb2- antigen in sections of formalin fixed, paraffin embedded normal and neoplastic tissue on a ventana automated immunohistochem-istry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom herceptin treatment is considered. Note: all of the patients in the herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using pathway her 2. The pathway her 2 was compared to the dako herceptest on an independent sample and found to provide acceptably concordant results. The actual correlation of pathway her 2 to clinical outcome has not been established. The ventana image analysis system (vias) is adjunctive optional computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection classification and counting of cells of interest based on market intensity, size and shape using appropriate controls to assure the validity of the vias scores.
| Device | PATHWAY HER-2/NEU (CLONE CD11) 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 | 2005-09-06 |
| Decision Date | 2005-10-21 |
| PMA | P990081 |
| Supplement | S002 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| 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 |