BRACAnalysis CDx

FDA Premarket Approval P140020 S021

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

Replacement of a confirmatory test reagent

DeviceBRACAnalysis CDx
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMYRIAD GENETIC LABORATORIES
Date Received2021-06-04
Decision Date2021-07-02
PMAP140020
SupplementS021
Product CodePJG 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MYRIAD GENETIC LABORATORIES 320 Wakara Way salt Lake City, UT 84108

Supplemental Filings

Supplement NumberDateSupplement Type
P140020Original Filing
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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