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 PD-L1 (SP263) Assay |
| Applicant | Ventana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS014 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-12 |
| Decision Date | 2022-07-29 |
| PMA | P160046 |
| Supplement | S014 |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| 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 PMA NumberP160046 Supplement NumberS014 Date Received07/12/2022 Decision Date07/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of Alternative Suppliers For Component Parts |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160046 | Original Filing | |
| S015 | 2022-10-14 | 30-day Notice |
| S014 | 2022-07-12 | 30-day Notice |
| S013 | ||
| S012 | 2022-02-16 | Special (immediate Track) |
| S011 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S010 | 2021-06-14 | Panel Track |
| S009 | 2021-02-22 | Real-time Process |
| S008 | 2020-08-26 | Real-time Process |
| S007 | 2020-01-13 | Real-time Process |
| S006 | 2019-08-22 | Real-time Process |
| S005 | 2018-06-18 | Real-time Process |
| S004 | 2018-04-03 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | ||
| S001 | 2017-07-17 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 04015630972784 | P160046 | 000 |