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 to extend the shelf life of the cologuard assay reagents(cologuard molecular assay reagents, cologuard molecular controls, cologuard hemoglobin assay reagents, and cologuard hemoglobin controls), on the basis of additional real-time stability testing, from a shelf-life of six (6) months to a shelf-life of nine (9) months.
| 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 | 2015-05-20 |
| Decision Date | 2015-08-18 |
| PMA | P130017 |
| Supplement | S002 |
| Product Code | PHP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |