Approval for the ventana pd-l1 (sp263) assay as a cdx for identifying patients with nsclc tumors with pd-l1 status of >= 1% tc who may benefit from treatment with tecentriq.
| Device | VENTANA PD-L1 (SP263) Assay |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | Ventana Medical Systems, Inc. |
| Date Received | 2021-06-14 |
| Decision Date | 2021-10-15 |
| PMA | P160046 |
| Supplement | S010 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Panel 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices