PMA
P150047: cobas EGFR MUTATION TEST v2
FDA PMA · Somatic gene mutation detection system · Roche Molecular Systems, Inc.
Key facts
| PMA number | P150047 |
|---|---|
| Trade name | cobas EGFR MUTATION TEST v2 |
| Generic name | Somatic gene mutation detection system |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | OWD |
| Approval date | Jun 1, 2016 |
| Docket number | 16M-1459 |
| Notice date | Jun 6, 2016 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 1–9 Supplements
- Oct 19, 2016 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: