Note: 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. |
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Device | MyChoice® CDx |
Applicant | Myriad Genetic Laboratories, Inc 320 Wankara Way Salt Lake City, UT 84108 |
PMA Number | P190014 |
Supplement Number | S008 |
Date Received | 01/20/2023 |
Decision Date | 10/27/2023 |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to replace the Illumina HiSeq 2500 Sequencer with the Illumina Next-generation Sequencer (NovaSeq 6000) for MyChoice CDx device. |
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