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 myriad mychoice® cdx to include a companion diagnostic indication for homologous recombination deficiency (hrd) in ovarian cancer patients who may benefit from maintenance treatment with lynparza® (olaparib)"
Device | myChoice CDx |
Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
Applicant | Myriad Genetic Laboratories, Inc |
Date Received | 2020-02-11 |
Decision Date | 2020-05-08 |
PMA | P190014 |
Supplement | S003 |
Product Code | PQP |
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, 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 |