EPi-Sense Guided Coagulation System
FDA premarket approval P200002/S001 · decided 2022-01-10
Approval details
- PMA number
- P200002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EPi-Sense Guided Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2021-08-31
- Decision date
- 2022-01-10
- Days to decision
- 132 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) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.