EPi-Sense Guided Coagulation System
FDA premarket approval P200002/S011 · decided 2025-06-17
Approval details
- PMA number
- P200002
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPi-Sense Guided Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2025-03-24
- Decision date
- 2025-06-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- an additional contract sterilizer and a process change to the ethylene oxide sterilization method
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