PMA P200002S013
- Device
- EPi-Sense ST Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S013
- Product code
- OCM
- Decision date
- 2025-11-14
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval for changes to the components located in the handle of the EPi-Sense ST probe
Current openFDA PMA Record#
- Device
- EPi-Sense ST Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S013
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2025-11-14
- Decision code
- APPR
- Date received
- 2025-08-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the components located in the handle of the EPi-Sense ST probe