Identity
- Trade Name
- EPi-Sense Guided Coagulation System FDA PMA
- Generic Name
- Surgical cardiac ablation device, for treatment of atrial fibrillation FDA PMA
Identifiers
- PMA Number
- P200002 FDA PMA
- FDA Product Code
- OCM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EPi-Sense Guided Coagulation System is a Surgical Cardiac Ablation Device designed for the treatment of atrial fibrillation. It employs guided coagulation to create controlled tissue lesions, facilitating ablation procedures in hybrid settings where both endocardial and epicardial approaches are combined. This system is intended for use in patients with long-standing persistent atrial fibrillation who are refractory or intolerant to antiarrhythmic drugs, under specific clinical conditions outlined in its approval.
The device is supplied as a Class III medical product, regulated under FDA PMA (Premarket Approval) with PMA number P200002. It is intended for single-use in controlled surgical environments, where sterility and precision are critical. The system includes components compatible with MRI safety standards as defined in its labeling, though specific MRI conditions must be verified per instructions. Storage and handling follow standard aseptic protocols for surgical devices, and its use is restricted to qualified healthcare providers in approved clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EPi-Sense ST Device | Hybrid AF Therapy - AtriCure, Inc., EPi-Sense System | AtriCure, EPi-Sense System - AtriCure, Inc., EPi-Sense® Guided Coagulation System - P200002 | FDA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200002 | Class III | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA PMA P200002 23 fields · synced Sep 18, 2026