myChoice CDx

FDA Premarket Approval P190014 S004

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.

Pre-market Approval Supplement Details

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).

DevicemyChoice CDx
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMyriad Genetic Laboratories, Inc
Date Received2020-07-28
Decision Date2021-01-27
PMAP190014
SupplementS004
Product CodePJG 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108

Supplemental Filings

Supplement NumberDateSupplement Type
P190014Original Filing
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

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