PMA
P200016: FoundationOne Liquid CDx
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Foundation Medicine, Inc.
Key facts
| PMA number | P200016 |
|---|---|
| Trade name | FoundationOne Liquid 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 6, 2020 |
| Docket number | 20M-2191 |
| Notice date | Nov 19, 2020 |
| Establishment registration | 3010679023 |
| FEI number | 3010679023 |
At a glance
- 1–9 Supplements
- Mar 8, 2023 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- No Withdrawn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: