PMA P200002S010
- Device
- EPi-Sense and EPi-Sense ST Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S010
- Product code
- OCM
- Decision date
- 2025-03-03
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- updates to the labeling of the Epi-Sense Guided Coagulation System
Current openFDA PMA Record#
- Device
- EPi-Sense and EPi-Sense ST Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S010
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2025-03-03
- Decision code
- APPR
- Date received
- 2025-02-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- updates to the labeling of the Epi-Sense Guided Coagulation System