COLOGUARD
FDA premarket approval P130017/S060 · decided 2024-11-12
Approval details
- PMA number
- P130017
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- Date received
- 2024-08-19
- Decision date
- 2024-11-12
- Days to decision
- 85 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Supplement P130017_S060 has been approved.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.