cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

FDA Premarket Approval P120019 S032

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

Manufacturing process change to use an alternate filter

Devicecobas EGFR Mutation Test and cobas EGFR Mutation Test v2
Generic NameSomatic Gene Mutation Detection System
Date Received2020-07-27
Decision Date2020-08-26
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE 4300 Hacienda Drive po Box 9002 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P120019Original Filing
S032 2020-07-27 30-day Notice
S030 2019-09-20 30-day Notice
S029 2019-06-27 Real-time Process
S028 2019-04-24 30-day Notice
S026 2018-11-13 30-day Notice
S025 2018-11-09 30-day Notice
S024 2018-08-21 30-day Notice
S023 2018-07-27 30-day Notice
S022 2018-06-08 30-day Notice
S021 2018-06-04 30-day Notice
S020 2018-03-01 30-day Notice
S019 2018-02-23 Normal 180 Day Track
S018 2017-11-30 Normal 180 Day Track
S017 2017-10-30 30-day Notice
S016 2017-10-27 Normal 180 Day Track
S015 2017-09-26 30-day Notice
S014 2017-07-17 30-day Notice
S013 2017-07-14 30-day Notice
S012 2016-09-22 30-day Notice
S011 2016-08-22 30-day Notice
S010 2016-07-08 30-day Notice
S009 2016-04-18 30-day Notice
S008 2015-06-24 30-day Notice
S007 2015-05-28 Panel Track
S006 2015-03-13 30-day Notice
S005 2014-12-19 30-day Notice
S004 2013-12-13 Real-time Process
S003 2013-08-14 30-day Notice
S002 2013-08-09 30-day Notice
S001 2013-07-26 30-day Notice

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