PMA P200002S001
- Device
- EPi-Sense Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S001
- Product code
- OCM
- Decision date
- 2022-01-10
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- EPi-Sense Guided Coagulation System
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S001
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2022-01-10
- Decision code
- APPR
- Date received
- 2021-08-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.