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 an update to the contamination detection algorithm which is a quality control change to the mychoice cdx device software.
| Device | myChoice HRD CDx |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | Myriad Genetic Laboratories, Inc |
| Date Received | 2021-05-28 |
| Decision Date | 2021-06-24 |
| PMA | P190014 |
| Supplement | S005 |
| Product Code | PJG |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190014 | Original Filing | |
| S007 | 2022-10-17 | Special (immediate Track) |
| S006 | 2021-06-07 | Normal 180 Day Track |
| S005 | 2021-05-28 | Special (immediate Track) |
| S004 | 2020-07-28 | Normal 180 Day Track |
| S003 | 2020-02-11 | Normal 180 Day Track |
| S002 | 2020-02-05 | Real-time Process |
| S001 | 2020-01-23 | Normal 180 Day Track |