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.
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement, which requested approval of the clinical protocol titled “a real-world study of patients under the age of 50 screened for colorectal cancer (crc) using cologuard® in the u. S. ‘tidal’,” for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p130017/s042/a001. Based upon the information submitted, the pma supplement is approved.
| Device | Cologuard |
| Generic Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Applicant | Exact Sciences Corporation |
| Date Received | 2020-05-27 |
| Decision Date | 2020-08-26 |
| PMA | P130017 |
| Supplement | S042 |
| Product Code | PHP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |