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 changes to the device labeling related to software/database and test report mockups
| Device | BRACAnalysis CDx |
| Classification Name | Cancer-related Germline Gene Mutation Detection System |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | MYRIAD GENETIC LABORATORIES |
| Date Received | 2018-03-22 |
| Decision Date | 2019-03-06 |
| PMA | P140020 |
| Supplement | S014 |
| Product Code | PJG |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MYRIAD GENETIC LABORATORIES 320 Wakara Way salt Lake City, UT 84108 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140020 | Original Filing | |
| S026 | 2023-01-11 | 30-day Notice |
| S025 | 2022-10-18 | Special (immediate Track) |
| S024 | 2022-10-14 | 30-day Notice |
| S023 | ||
| S022 | 2021-10-22 | Normal 180 Day Track |
| S021 | 2021-06-04 | 30-day Notice |
| S020 | 2019-12-06 | Normal 180 Day Track |
| S019 | 2019-07-02 | Normal 180 Day Track |
| S018 | 2018-09-21 | Normal 180 Day Track |
| S017 | 2018-07-31 | Real-time Process |
| S016 | 2018-06-29 | Normal 180 Day Track |
| S015 | 2018-04-09 | Normal 180 Day Track |
| S014 | 2018-03-22 | Normal 180 Day Track |
| S013 | 2017-09-29 | 30-day Notice |
| S012 | 2017-08-31 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | 2016-12-20 | Normal 180 Day Track |
| S008 | 2016-10-27 | Normal 180 Day Track |
| S007 | 2016-06-07 | Real-time Process |
| S006 | 2016-03-23 | Real-time Process |
| S005 | 2015-01-21 | 30-day Notice |
| S004 | 2015-11-25 | 30-day Notice |
| S003 | 2015-09-17 | Real-time Process |
| S002 | 2015-07-22 | Real-time Process |
| S001 | 2015-06-19 | Real-time Process |