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 of guardant360 cdx for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with kras g12c mutation for treatment with lumakrastm (sotorasib).
| Device | Guardant360 CDx |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Guardant Health, Inc. |
| Date Received | 2020-12-18 |
| Decision Date | 2021-05-28 |
| PMA | P200010 |
| Supplement | S002 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Guardant Health, Inc. 505 Penobscot Drive redwood City, CA 94063 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200010 | Original Filing | |
| S011 | 2022-07-01 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | ||
| S007 | 2022-02-02 | 30-day Notice |
| S006 | ||
| S005 | 2021-12-17 | Real-time Process |
| S004 | ||
| S003 | ||
| S002 | 2020-12-18 | Panel Track |
| S001 | 2020-11-20 | Panel Track |