Cologuard

FDA Premarket Approval P130017 S043

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 changes to tube assembly

DeviceCologuard
Generic NameSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
ApplicantExact Sciences Corporation
Date Received2020-09-09
Decision Date2020-10-07
PMAP130017
SupplementS043
Product CodePHP 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Exact Sciences Corporation 441 Charmany Drive madison, WI 53719

Supplemental Filings

Supplement NumberDateSupplement Type
P130017Original Filing
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

Device IDPMASupp
00858637005314 P130017 000
00858637005086 P130017 000
00858637005079 P130017 000
00858637005062 P130017 000
00858637005055 P130017 000
00858637005048 P130017 000
00858637005031 P130017 000
00858637005017 P130017 000
00858637005000 P130017 000
00858637005413 P130017 000
00858637005406 P130017 000
00858637005390 P130017 000
00858637005352 P130017 000
00858637005321 P130017 000
00858637005383 P130017 000
00858637005369 P130017 000
00858637005208 P130017 000
00858637005093 P130017 000
00858637005109 P130017 000
00858637005307 P130017 000
00858637005291 P130017 000
00858637005284 P130017 000
00858637005253 P130017 000
00858637005246 P130017 000
00858637005239 P130017 000
00858637005222 P130017 000
00858637005215 P130017 000
00858637005185 P130017 000
00858637005178 P130017 000
00858637005161 P130017 000
00858637005154 P130017 000
00858637005147 P130017 000
00858637005130 P130017 000
00858637005123 P130017 000
00858637005116 P130017 000
00858637005277 P130017 000

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