COLOGUARD

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Premarket Approval P130017

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the cologuard. Cologuard is intended for the qualitative detection of colorectal neoplasia associated dna markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (crc) or advanced adenoma (aa) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for crc. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.

DeviceCOLOGUARD
Classification NameSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Generic NameSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
ApplicantExact Sciences Corporation
Date Received2013-06-07
Decision Date2014-08-11
Notice Date2014-08-13
PMAP130017
SupplementS
Product CodePHP
Docket Number14M-1193
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address Exact Sciences Corporation 441 Charmany Drive madison, WI 53719
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P130017Original Filing
S054 2022-07-11 30-day Notice
S053 2022-06-21 30-day Notice
S052 2022-06-08 30-day Notice
S051 2022-03-02 Real-time Process
S050 2021-09-13 Real-time Process
S049 2021-09-07 30-day Notice
S048 2021-03-01 30-day Notice
S047 2021-02-22 30-day Notice
S046
S045 2020-10-30 30-day Notice
S044 2020-09-18 30-day Notice
S043 2020-09-09 30-day Notice
S042 2020-05-27 Normal 180 Day Track No User Fee
S041 2020-05-20 30-day Notice
S040 2020-04-17 30-day Notice
S039 2020-03-16 30-day Notice
S038 2020-02-14 30-day Notice
S037
S036 2019-09-27 30-day Notice
S035 2019-09-27 30-day Notice
S034 2019-09-19 30-day Notice
S033
S032 2019-08-12 30-day Notice
S031 2019-05-16 30-day Notice
S030 2019-04-16 30-day Notice
S029
S028 2019-02-21 30-day Notice
S027
S026 2019-02-07 30-day Notice
S025 2019-01-22 30-day Notice
S024 2018-10-17 30-day Notice
S023 2018-07-30 30-day Notice
S022 2018-01-25 30-day Notice
S021 2017-12-01 30-day Notice
S020 2017-07-25 30-day Notice
S019 2017-06-09 30-day Notice
S018 2017-06-05 30-day Notice
S017 2017-05-22 Normal 180 Day Track
S016 2017-04-25 30-day Notice
S015 2017-03-06 Real-time Process
S014 2016-11-14 Special (immediate Track)
S013 2016-11-01 30-day Notice
S012 2016-11-01 30-day Notice
S011 2016-07-14 30-day Notice
S010 2016-05-31 Real-time Process
S009 2016-04-14 30-day Notice
S008 2016-04-11 30-day Notice
S007 2016-03-22 30-day Notice
S006 2016-01-27 30-day Notice
S005 2015-12-04 30-day Notice
S004 2015-07-27 Normal 180 Day Track No User Fee
S003 2015-06-04 Real-time Process
S002 2015-05-20 Real-time Process
S001 2014-09-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

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