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 | VENTANA ALK (D5F3) CDx Assay |
| Generic Name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Applicant | VENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW 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 | P140025 |
| Supplement | S017 |
| Product Code | PKW |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate 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 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductYes 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 |
|---|---|---|
| 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 |