Transfer of scaled-up manufacturing processes and testing methods to a previously approved manufacturing facility
| Device | Cologuard |
| Generic Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Applicant | Exact Sciences Corporation |
| Date Received | 2021-03-01 |
| Decision Date | 2021-03-25 |
| PMA | P130017 |
| Supplement | S048 |
| Product Code | PHP |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Exact Sciences Corporation 441 Charmany Drive madison, WI 53719 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130017 | | Original Filing |
| 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 |
NIH GUDID Devices