cobas® EGFR Mutation Test, v2.0

FDA Premarket Approval P120019 S034

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

Devicecobas® EGFR Mutation Test, v2.0
Generic NameSomatic Gene Mutation Detection System
ApplicantROCHE4300 Hacienda Drivepo Box 9002pleasanton, CA 94588 PMA NumberP120019 Supplement NumberS034 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-21
Decision Date2022-11-14
PMAP120019
SupplementS034
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressROCHE
4300 Hacienda Drive
po Box 9002
pleasanton, CA 94588 PMA NumberP120019 Supplement NumberS034 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
removal Of An In-process Testing (IPT) From The Manufacturing Process

Supplemental Filings

Supplement NumberDateSupplement Type
P120019Original Filing
S034 2022-10-21 30-day Notice
S033
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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