EPi-Sense ST Coagulation System
FDA premarket approval P200002/S013 · decided 2025-11-14
Approval details
- PMA number
- P200002
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPi-Sense ST Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2025-08-18
- Decision date
- 2025-11-14
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for changes to the components located in the handle of the EPi-Sense ST probe
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