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 |
Generic Name | Cancer-related germline gene mutation detection system |
Applicant | Myriad Genetic Laboratories, Inc 320 Wankara Way Salt Lake City, UT 84108 |
PMA Number | P190014 |
Supplement Number | S006 |
Date Received | 06/07/2021 |
Decision Date | 02/10/2022 |
Product Code |
PJG |
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 of an upgraded version of MyChoice CDx (version 2) due to reagent change to the device. |
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