PMA supplement
P200010 S008: Guardant360 CDx
FDA PMA supplement · Panel Track · Guardant Health, Inc.
Key facts
| Original PMA | P200010 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Guardant360 CDx |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Guardant Health, Inc. |
| Product code | PQP |
| Received date | Apr 13, 2022 |
| Decision date | Aug 11, 2022 |
| Docket number | 22M-1953 |
| Notice date | Aug 19, 2022 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: