FDA.reportPublic FDA data

PMA P130017S050

Device
Cologuard®
Applicant
Exact Sciences Corporation
PMA number
P130017
Supplement
S050
Product code
PHP
Decision date
2021-12-13
Generic name
System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement
Approval of a design change to modify the hemoglobin stabilization buffer formulation to support extending the specimen stability to 96 hours, and the labeling update to reflect the change.

Current openFDA PMA Record#

Device
Cologuard®
Applicant
Exact Sciences Corporation
PMA number
P130017
Supplement
S050
Product code
PHP
Generic name
System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date
2021-12-13
Decision code
APPR
Date received
2021-09-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of a design change to modify the hemoglobin stabilization buffer formulation to support extending the specimen stability to 96 hours, and the labeling update to reflect the change.