PMA
P170019: FoundationOne CDx
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Foundation Medicine, Inc.
Key facts
| PMA number | P170019 |
|---|---|
| Trade name | FoundationOne CDx |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Foundation Medicine, Inc. |
| Owner/operator | Foundation Medicine, Inc. |
| Product code | PQP |
| Approval date | Nov 30, 2017 |
| Docket number | 17M-6799 |
| Notice date | Dec 15, 2017 |
| Establishment registration | 3010679023 |
| FEI number | 3010679023 |
At a glance
- 10–99 Supplements
- Sep 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: