PMA supplement
P120019 S007: COBAS EGFR MUTATION TEST V2
FDA PMA supplement · Panel Track · Roche
Key facts
| Original PMA | P120019 |
|---|---|
| Supplement number | S007 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | COBAS EGFR MUTATION TEST V2 |
| Generic name | Somatic gene mutation detection system |
| Applicant | Roche |
| Product code | OWD |
| Received date | May 28, 2015 |
| Decision date | Nov 13, 2015 |
| Docket number | 15M-4344 |
| Notice date | Nov 30, 2015 |
At a glance
- Yes Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: