- Device
- EPi-Sense Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S007
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2023-11-22
- Decision code
- APPR
- Date received
- 2023-08-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor software modifications to the Multifunctional Ablation Generator (MAG) system controller software.