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 extending the label claim of the ventana alk (d5f3) cdx assay to include an indication for zykadia (ceritinib)
| Device | VENTANA ALK (D5F3) CDX ASSAY |
| Classification Name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Generic Name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2016-12-28 |
| Decision Date | 2017-05-26 |
| PMA | P140025 |
| Supplement | S005 |
| Product Code | PKW |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140025 | Original Filing | |
| S018 | 2022-07-12 | 30-day Notice |
| S017 | 2022-02-16 | Special (immediate Track) |
| S016 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S015 | 2021-02-22 | Real-time Process |
| S014 | 2020-11-16 | Normal 180 Day Track |
| S013 | 2020-08-26 | Real-time Process |
| S012 | 2020-01-13 | Real-time Process |
| S011 | 2019-08-22 | Real-time Process |
| S010 | 2018-11-09 | 30-day Notice |
| S009 | 2018-06-18 | Real-time Process |
| S008 | ||
| S007 | 2017-07-17 | 30-day Notice |
| S006 | 2017-06-07 | Normal 180 Day Track |
| S005 | 2016-12-28 | Normal 180 Day Track |
| S004 | 2016-11-15 | Normal 180 Day Track |
| S003 | 2016-03-22 | Normal 180 Day Track |
| S002 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S001 | 2015-08-26 | 30-day Notice |