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.
Approval for several minor modifications to the test definitionsoftware for cologuard¿.
| 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 | 2015-06-04 |
| Decision Date | 2015-08-19 |
| PMA | P130017 |
| Supplement | S003 |
| Product Code | PHP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Exact Sciences Corporation 441 Charmany Drive madison, WI 53719 |
| 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 |