EPi-Sense and EPi-Sense ST Guided Coagulation System
FDA premarket approval P200002/S010 · decided 2025-03-03
Approval details
- PMA number
- P200002
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EPi-Sense and EPi-Sense ST Guided Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2025-02-03
- Decision date
- 2025-03-03
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- updates to the labeling of the Epi-Sense Guided Coagulation System
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