PMA P130017S015
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S015
- Product code
- PHP
- Decision date
- 2017-05-24
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Approval for the changes to the EXACT System Software for Cologuard.
Current openFDA PMA Record#
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S015
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2017-05-24
- Decision code
- APPR
- Date received
- 2017-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the changes to the EXACT System Software for Cologuard.