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.
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.
| Device | COLOGUARD |
| Classification Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Generic Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Applicant | Exact Sciences Corporation |
| Date Received | 2013-06-07 |
| Decision Date | 2014-08-11 |
| Notice Date | 2014-08-13 |
| PMA | P130017 |
| Supplement | S |
| Product Code | PHP |
| Docket Number | 14M-1193 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130017 | Original 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 |