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 for software modification in the benchmark xt from nexes to vss 12. 5 and associated hardware changes.
| Device | PATHWAY anti-HER-2/neu (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 | 2016-11-15 |
| Decision Date | 2017-03-13 |
| PMA | P990081 |
| Supplement | S035 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |