PMA P200002S014
- Device
- EPi-Sense and EPi-Sense ST Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S014
- Product code
- OCM
- Decision date
- 2026-05-06
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- approval for labeling changes intended to enhance the safe use of the device
Current openFDA PMA Record#
- Device
- EPi-Sense and EPi-Sense ST Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S014
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2026-05-06
- Decision code
- APPR
- Date received
- 2026-04-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for labeling changes intended to enhance the safe use of the device