PMA
P160018: FoundationFocus CDxBRCA
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Foundation Medicine, Inc.
Key facts
| PMA number | P160018 |
|---|---|
| Trade name | FoundationFocus CDxBRCA |
| 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 | Dec 19, 2016 |
| Docket number | 16M-4459 |
| Notice date | Jan 12, 2017 |
| Establishment registration | 3010679023 |
| FEI number | 3010679023 |
At a glance
- 1–9 Supplements
- Apr 6, 2018 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- No Withdrawn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: