Guardant Health, Inc.: PMA supplement approved for Guardant360 CDx
Guardant Health, Inc. (Redwood City, California): PMA supplement approved for Guardant360 CDx. Dated 47 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 109 related CA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Guardant Health, Inc. |
| Product | Guardant360 CDx |
| Generic / ingredient | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Approval | PMA supplement (device change) |
| Application | P200010 S029 |
| Decided | 2026-09-18 |
| Panel / class | Pathology |
| Sponsor location | Redwood City, CA |
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| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-09-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (CA first): Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · ABBOTT MEDICAL · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Guardant Health, Inc. and 110 California peers
- California FdaApprovalPulse records like this one: 110
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $22,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Guardant Health, Inc. in Redwood City, California?
The FDA approved Guardant360 CDx (P200010 S029) for Guardant Health, Inc. on 2026-09-18: PMA supplement (device change).
How does Guardant Health, Inc. compare to other California FdaApprovalPulse records?
It is 47 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Guardant Health, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Guardant Health, Inc. | Redwood City, CA | 2026-09-18 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-22 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.