MyChoice CDx®

FDA Premarket Approval P190014 S007

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

DeviceMyChoice CDx®
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMyriad Genetic Laboratories, Inc320 Wankara Waysalt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-10-17
Decision Date2022-11-14
PMAP190014
SupplementS007
Product CodePJG 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressMyriad Genetic Laboratories, Inc
320 Wankara Way
salt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approved Removal Of The Companion Diagnostic Indication For MyChoice® CDx To Identify Patients With Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer With Homologous Recombination Deficiency (HRD) Positive Status For Treatment With Zejula (niraparib).

Supplemental Filings

Supplement NumberDateSupplement Type
P190014Original 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

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