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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicemyChoice CDx
Generic NameCancer-related germline gene mutation detection system
ApplicantMyriad Genetic Laboratories, Inc
320 Wankara Way
Salt Lake City, UT 84108
PMA NumberP190014
Supplement NumberS004
Date Received07/28/2020
Decision Date01/27/2021
Product Code PJG 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Myriad myChoice® CDx to expand labeling based on SOLO1 study for the treatment of the patients with BRCA mutated advanced ovarian cancer with LYNPARZA (olaparib).
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