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 | Guardant360 CDx |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS005 Date Received12/17/2021 Decision Date03/16/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-03-16 |
| PMA | P200010 |
| Supplement | S005 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Guardant Health, Inc. 505 Penobscot Drive redwood City, CA 94063 PMA NumberP200010 Supplement NumberS005 Date Received12/17/2021 Decision Date03/16/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Use Reagent Lots Interchangeably For Guardant360 CDx Sample Preparation Kit Boxes And A Minor Software Update To Accommodate The Reagent Interchangeability Update. |
| 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 |