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 to expand the intended use of bracanalysis® cdx to include a companion diagnostic indication for brca1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with lynparza® (olaparib).
Device | BRACAnalysis CDx |
Generic Name | Cancer-related Germline Gene Mutation Detection System |
Applicant | MYRIAD GENETIC LABORATORIES |
Date Received | 2019-12-06 |
Decision Date | 2020-05-19 |
PMA | P140020 |
Supplement | S020 |
Product Code | PJG |
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 |