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
ApplicantROCHE
Date Received2020-07-27
Decision Date2020-08-26
PMAP120019
SupplementS032
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
S031
S030 2019-09-20 30-day Notice
S029 2019-06-27 Real-time Process
S028 2019-04-24 30-day Notice
S027
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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