PMA P130017S048
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S048
- Product code
- PHP
- Decision date
- 2021-03-25
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Transfer of scaled-up manufacturing processes and testing methods to a previously approved manufacturing facility.
Current openFDA PMA Record#
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S048
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2021-03-25
- Decision code
- OK30
- Date received
- 2021-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of scaled-up manufacturing processes and testing methods to a previously approved manufacturing facility.