PMA P130017S038
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S038
- Product code
- PHP
- Decision date
- 2020-03-12
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Process changes related to reagent manufacturing scale-up.
Current openFDA PMA Record#
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S038
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2020-03-12
- Decision code
- OK30
- Date received
- 2020-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process changes related to reagent manufacturing scale-up.