COLOGUARD
FDA premarket approval P130017/S004 · decided 2015-09-25
Approval details
- PMA number
- P130017
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- COLOGUARD
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2015-07-27
- Decision date
- 2015-09-25
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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