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 | MyChoice CDx® |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | Myriad Genetic Laboratories, Inc320 Wankara Waysalt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 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 | 2022-10-17 |
| Decision Date | 2022-11-14 |
| PMA | P190014 |
| Supplement | S007 |
| 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, Inc 320 Wankara Way salt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 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 Approved Removal Of The Companion Diagnostic Indication For MyChoice® CDx To Identify Patients With Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer With Homologous Recombination Deficiency (HRD) Positive Status For Treatment With Zejula (niraparib). |
| 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 |