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 addition of poly ra to the braf mutant and wild-type controls buffer matrix and associated manufacturing process changes.
| Device | ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190 |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2012-09-12 |
| Decision Date | 2013-01-10 |
| PMA | P110020 |
| Supplement | S006 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110020 | Original Filing | |
| S037 | 2022-10-21 | 30-day Notice |
| S036 | ||
| S035 | 2020-07-27 | 30-day Notice |
| S034 | 2019-09-20 | 30-day Notice |
| S033 | 2019-06-27 | Real-time Process |
| S032 | 2019-04-24 | 30-day Notice |
| S031 | 2018-11-13 | 30-day Notice |
| S030 | 2018-11-09 | 30-day Notice |
| S029 | 2018-08-21 | 30-day Notice |
| S028 | 2018-07-27 | 30-day Notice |
| S027 | 2018-06-29 | 30-day Notice |
| S026 | 2018-06-08 | 30-day Notice |
| S025 | 2018-06-04 | 30-day Notice |
| S024 | 2018-03-01 | 30-day Notice |
| S023 | 2017-10-30 | 30-day Notice |
| S022 | 2017-09-26 | 30-day Notice |
| S021 | 2017-07-17 | 30-day Notice |
| S020 | 2017-07-14 | 30-day Notice |
| S019 | 2017-07-14 | 30-day Notice |
| S018 | 2016-08-22 | 30-day Notice |
| S017 | 2016-07-08 | 30-day Notice |
| S016 | 2016-06-30 | Normal 180 Day Track |
| S015 | 2016-04-18 | 30-day Notice |
| S014 | 2015-06-24 | 30-day Notice |
| S013 | 2015-03-13 | 30-day Notice |
| S012 | 2014-12-19 | 30-day Notice |
| S011 | 2013-12-13 | 30-day Notice |
| S010 | 2013-12-13 | Real-time Process |
| S009 | 2013-08-14 | 30-day Notice |
| S008 | 2013-08-09 | 30-day Notice |
| S007 | 2013-07-26 | 30-day Notice |
| S006 | 2012-09-12 | Normal 180 Day Track |
| S005 | 2012-08-15 | 30-day Notice |
| S004 | 2012-07-02 | Real-time Process |
| S003 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S002 | 2011-09-29 | 30-day Notice |
| S001 | 2011-09-19 | 30-day Notice |