This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the revised instructions for use for the cobas® ezh2 mutation test.
| Device | cobas® EZH2 Mutation Test |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular System, Inc. |
| Date Received | 2021-02-22 |
| Decision Date | 2021-08-10 |
| PMA | P200014 |
| Supplement | S003 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular System, Inc. 4300 Hacienda Drive pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200014 | Original Filing | |
| S004 | 2022-10-18 | 30-day Notice |
| S003 | 2021-02-22 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2020-07-27 | 30-day Notice |