PMA P130017S046
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- Product code
- PHP
- Decision date
- 2021-04-12
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Changes required for manufacturing scale-up of a device component.
Current openFDA PMA Record#
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S046
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2021-04-12
- Decision code
- OK30
- Date received
- 2021-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes required for manufacturing scale-up of a device component.