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.
Changes to the filling and labeling equipment and location for certain vialed intermediate components. Your firm has proposed relocation to building 502 rooms1f24 and 1f26 from building 502 rooms 1f23 and 1f31 for use of new equipment kugler linoline 120 filing and screw-capping line which includes the accraply 4000 and 35t labelingmachines.
| Device | COBAS 4800 BRAF V600 MUTATION TEST |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2011-09-29 |
| Decision Date | 2011-10-26 |
| PMA | P110020 |
| 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 |
|---|---|---|
| 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 |