EPi-Sense Guided Coagulation System
FDA premarket approval P200002 · decided 2021-04-28
Approval details
- PMA number
- P200002
- Trade name
- EPi-Sense Guided Coagulation System
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2020-01-02
- Decision date
- 2021-04-28
- Days to decision
- 482 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Approval for the EPi-Sense Guided Coagulation System is intended for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD); and, in whom the expected benefit from rhythm control outweighs the potential known
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