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