cobas BRAF V600 Mutation Test

FDA Premarket Approval P110020 S035

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 BRAF V600 Mutation Test
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular Systems, Inc.
Date Received2020-07-27
Decision Date2020-08-26
PMAP110020
SupplementS035
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P110020Original Filing
S035 2020-07-27 30-day Notice
S034 2019-09-20 30-day Notice
S033 2019-06-27 Real-time Process
S032 2019-04-24 30-day Notice
S031 2018-11-13 30-day Notice
S030 2018-11-09 30-day Notice
S029 2018-08-21 30-day Notice
S028 2018-07-27 30-day Notice
S027 2018-06-29 30-day Notice
S026 2018-06-08 30-day Notice
S025 2018-06-04 30-day Notice
S024 2018-03-01 30-day Notice
S023 2017-10-30 30-day Notice
S022 2017-09-26 30-day Notice
S021 2017-07-17 30-day Notice
S020 2017-07-14 30-day Notice
S019 2017-07-14 30-day Notice
S018 2016-08-22 30-day Notice
S017 2016-07-08 30-day Notice
S016 2016-06-30 Normal 180 Day Track
S015 2016-04-18 30-day Notice
S014 2015-06-24 30-day Notice
S013 2015-03-13 30-day Notice
S012 2014-12-19 30-day Notice
S011 2013-12-13 30-day Notice
S010 2013-12-13 Real-time Process
S009 2013-08-14 30-day Notice
S008 2013-08-09 30-day Notice
S007 2013-07-26 30-day Notice
S006 2012-09-12 Normal 180 Day Track
S005 2012-08-15 30-day Notice
S004 2012-07-02 Real-time Process
S003 2011-12-12 135 Review Track For 30-day Notice
S002 2011-09-29 30-day Notice
S001 2011-09-19 30-day Notice

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