Note: 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. |
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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 | S055 |
Date Received | 12/19/2022 |
Decision Date | 03/16/2023 |
Product Code |
PHP |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a Cologuard Quick Start Guide (QSG), to be a companion document to the Cologuard Patient Guide, as part of the Cologuard User Interface. |
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