EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System
FDA premarket approval P200002/S008 · decided 2023-12-11
Approval details
- PMA number
- P200002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2023-09-05
- Decision date
- 2023-12-11
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200002.
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