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 of ge healthcare sourced material manufactured at the thermofisher scientific facility located in vilnius, lithuania as an approved supplier of polyadenylic acid polymer, potassium salt (poly a) for the roche molecular systems facility in branchburg, new jersey.
| Device | ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2015-09-02 |
| Decision Date | 2015-09-24 |
| PMA | P140023 |
| Supplement | S002 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140023 | Original Filing | |
| S025 | 2022-10-21 | 30-day Notice |
| S024 | ||
| S023 | 2020-07-27 | 30-day Notice |
| S022 | 2020-02-18 | Real-time Process |
| S021 | 2019-09-20 | 30-day Notice |
| S020 | 2019-04-24 | 30-day Notice |
| S019 | 2018-11-13 | 30-day Notice |
| S018 | 2018-11-09 | 30-day Notice |
| S017 | 2018-08-21 | 30-day Notice |
| S016 | 2018-07-27 | 30-day Notice |
| S015 | 2018-06-08 | 30-day Notice |
| S014 | 2018-06-04 | 30-day Notice |
| S013 | 2018-03-01 | 30-day Notice |
| S012 | 2017-10-30 | 30-day Notice |
| S011 | 2017-09-27 | 30-day Notice |
| S010 | 2017-07-17 | 30-day Notice |
| S009 | 2017-07-14 | 30-day Notice |
| S008 | 2016-09-22 | 30-day Notice |
| S007 | 2016-08-22 | 30-day Notice |
| S006 | 2016-07-08 | 30-day Notice |
| S005 | 2016-04-18 | 30-day Notice |
| S004 | 2016-02-29 | Normal 180 Day Track |
| S003 | 2016-01-28 | Real-time Process |
| S002 | 2015-09-02 | 30-day Notice |
| S001 | 2015-06-24 | 30-day Notice |