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PMA P130017S042

Device
Cologuard
Applicant
Exact Sciences Corporation
PMA number
P130017
Supplement
S042
Product code
PHP
Decision date
2020-08-26
Generic name
System, colorectal neoplasia, DNA methylation and hemoglobin detection
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.

Current openFDA PMA Record#

Device
Cologuard
Applicant
Exact Sciences Corporation
PMA number
P130017
Supplement
S042
Product code
PHP
Generic name
System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date
2020-08-26
Decision code
APPR
Date received
2020-05-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
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.