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.
Manufacturing process change to use an alternate filter
| Device | cobas® EZH2 Mutation Test |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular System, Inc. |
| Date Received | 2020-07-27 |
| Decision Date | 2020-08-26 |
| PMA | P200014 |
| Supplement | S001 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |