PMA P200002S015
- Device
- EPi- Sense ST Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S015
- Product code
- OCM
- Decision date
- 2026-09-24
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- an alternate sterilization cycle
Current openFDA PMA Record#
- Device
- EPi- Sense ST Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S015
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2026-09-24
- Decision code
- OK30
- Date received
- 2026-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate sterilization cycle