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.
| Device | PATHWAY Anti-c-KIT (9.7) Primary Antibody |
| Generic Name | Immunohistochemistry Antibody Assay, C-kit |
| Applicant | VENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-02-16 |
| Decision Date | 2022-07-21 |
| PMA | P020055 |
| Supplement | S026 |
| Product Code | NKF |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| 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 PMA NumberP020055 Supplement NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020055 | Original Filing | |
| S028 | 2022-10-14 | 30-day Notice |
| S027 | 2022-07-12 | 30-day Notice |
| S026 | 2022-02-16 | Special (immediate Track) |
| S025 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S024 | 2021-02-22 | Real-time Process |
| S023 | 2020-08-26 | Real-time Process |
| S022 | 2020-01-13 | Real-time Process |
| S021 | ||
| S020 | 2017-07-17 | 30-day Notice |
| S019 | 2016-11-15 | Normal 180 Day Track |
| S018 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S017 | 2015-08-26 | 30-day Notice |
| S016 | 2014-10-27 | 30-day Notice |
| S015 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S014 | 2014-02-06 | Real-time Process |
| S013 | 2014-01-06 | 30-day Notice |
| S012 | 2013-11-12 | 30-day Notice |
| S011 | 2013-10-28 | 30-day Notice |
| S010 | 2013-10-11 | Normal 180 Day Track |
| S009 | 2013-08-30 | 30-day Notice |
| S008 | 2013-05-06 | Real-time Process |
| S007 | 2013-04-17 | 30-day Notice |
| S006 | 2013-03-04 | 30-day Notice |
| S005 | 2012-12-11 | Real-time Process |
| S004 | 2012-08-31 | Real-time Process |
| S003 | 2012-06-26 | 30-day Notice |
| S002 | 2011-05-23 | Normal 180 Day Track |
| S001 | 2007-04-16 | 30-day Notice |