BRACAnalysis CDx®

FDA Premarket Approval P140020 S025

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

DeviceBRACAnalysis CDx®
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-10-18
Decision Date2022-11-16
PMAP140020
SupplementS025
Product CodePJG 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressMYRIAD GENETIC LABORATORIES
320 Wakara Way
salt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 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  
Removal Of The Companion Diagnostic Indication For BRACAnalysis CDx To Identify Patients With Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer With Homologous Recombination Deficiency (HRD) Positive Status For Treatment With Lynparza® (olaparib) And Rubraca® (rucaparib).

Supplemental Filings

Supplement NumberDateSupplement Type
P140020Original Filing
S025 2022-10-18 Special (immediate Track)
S024 2022-10-14 30-day Notice
S023
S022 2021-10-22 Normal 180 Day Track
S021 2021-06-04 30-day Notice
S020 2019-12-06 Normal 180 Day Track
S019 2019-07-02 Normal 180 Day Track
S018 2018-09-21 Normal 180 Day Track
S017 2018-07-31 Real-time Process
S016 2018-06-29 Normal 180 Day Track
S015 2018-04-09 Normal 180 Day Track
S014 2018-03-22 Normal 180 Day Track
S013 2017-09-29 30-day Notice
S012 2017-08-31 Normal 180 Day Track
S011
S010
S009 2016-12-20 Normal 180 Day Track
S008 2016-10-27 Normal 180 Day Track
S007 2016-06-07 Real-time Process
S006 2016-03-23 Real-time Process
S005 2015-01-21 30-day Notice
S004 2015-11-25 30-day Notice
S003 2015-09-17 Real-time Process
S002 2015-07-22 Real-time Process
S001 2015-06-19 Real-time Process

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