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 changes in quality controls to ensure the safety in the use of the device by: 1) adding a test to ensure appropriate stain intensity of the primary antibody at the bulk manufacturing stages; and 2) adding a quality control testing steps at the raw material production and bulk manufacturing stages.
| Device | PATHWAY ANTI-HER 2INEU (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 | 2010-10-21 |
| Decision Date | 2010-11-17 |
| PMA | P990081 |
| Supplement | S008 |
| Product Code | MVC |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |