PMA P130017S001
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S001
- Product code
- PHP
- Decision date
- 2015-02-02
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S001
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2015-02-02
- Decision code
- APPR
- Date received
- 2014-09-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.