|
Device | Cologuard |
Generic Name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
Applicant | Exact Sciences Corporation 441 Charmany Drive Madison, WI 53719 |
PMA Number | P130017 |
Supplement Number | S042 |
Date Received | 05/27/2020 |
Decision Date | 08/26/2020 |
Product Code |
PHP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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) protocol. |