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 expansion of the indications for use as a companion diagnostic for lynparza (olaparib) inpancreatic cancer patients
| Device | BRACAnalysis CDx |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | MYRIAD GENETIC LABORATORIES |
| Date Received | 2019-07-02 |
| Decision Date | 2019-12-27 |
| PMA | P140020 |
| Supplement | S019 |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |