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.
| Device | BRACAnalysis CDx® |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-10-18 |
| Decision Date | 2022-11-16 |
| PMA | P140020 |
| Supplement | S025 |
| Product Code | PJG |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate 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 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Removal Of The Companion Diagnostic Indication For BRACAnalysis CDx To Identify Patients With Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer With Homologous Recombination Deficiency (HRD) Positive Status For Treatment With Lynparza® (olaparib) And Rubraca® (rucaparib). |
| 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 |