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 the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.
| Device | INFORM HER2 Dual ISH DNA Probe Cocktail |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2021-02-22 |
| Decision Date | 2021-05-20 |
| PMA | P100027 |
| Supplement | S034 |
| Product Code | NYQ |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100027 | Original Filing | |
| S038 | 2022-10-14 | 30-day Notice |
| S037 | 2022-07-12 | 30-day Notice |
| S036 | 2022-02-16 | Special (immediate Track) |
| S035 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S034 | 2021-02-22 | Real-time Process |
| S033 | 2020-08-26 | Real-time Process |
| S032 | 2020-01-13 | Real-time Process |
| S031 | 2019-08-22 | Real-time Process |
| S030 | 2019-02-13 | Normal 180 Day Track |
| S029 | 2018-06-18 | Real-time Process |
| S028 | ||
| S027 | 2017-07-17 | 30-day Notice |
| S026 | 2016-11-15 | Normal 180 Day Track |
| S025 | 2016-11-04 | 30-day Notice |
| S024 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S023 | 2015-08-26 | 30-day Notice |
| S022 | 2015-08-14 | 30-day Notice |
| S021 | 2015-02-11 | 30-day Notice |
| S020 | 2014-10-27 | 30-day Notice |
| S019 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S018 | 2014-05-01 | Real-time Process |
| S017 | 2014-02-06 | Real-time Process |
| S016 | 2014-01-22 | Real-time Process |
| S015 | 2014-01-06 | 30-day Notice |
| S014 | 2013-12-27 | 30-day Notice |
| S013 | 2013-11-12 | 30-day Notice |
| S012 | 2013-10-28 | 30-day Notice |
| S011 | 2013-09-12 | 30-day Notice |
| S010 | 2013-05-07 | 30-day Notice |
| S009 | 2013-05-06 | Real-time Process |
| S008 | 2013-04-17 | 30-day Notice |
| S007 | 2013-03-12 | Real-time Process |
| S006 | 2013-03-04 | 30-day Notice |
| S005 | 2012-10-10 | Normal 180 Day Track |
| S004 | 2012-09-26 | Real-time Process |
| S003 | 2012-08-31 | Real-time Process |
| S002 | 2011-09-19 | Normal 180 Day Track |
| S001 | 2011-08-29 | Real-time Process |