ATRICURE SYNERGY ABLATION SYSTEM
FDA premarket approval P100046 · decided 2011-12-14
Approval details
- PMA number
- P100046
- Trade name
- ATRICURE SYNERGY ABLATION SYSTEM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2010-12-23
- Decision date
- 2011-12-14
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Mason, OH
- Statement
- APPROVAL FOR THE ATRICURE SYNERGY ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR THE ABLATION OF CARDIAC TISSUE FOR THETREATMENT OF PERSISTENT ATRIAL FIBRILLATION (SUSTAINED BEYOND SEVEN DAYS, OR LASTING LESS THAN SEVEN DAYS BUT NECESSITATING PHARMACOLOGIC OR ELECTRICAL CARDIOVERSION) OR LONGSTANDING PERSISTENT ATRIALFIBRILLATION (CONTINUOUS ATRIAL FIBRILLATION OF GREATER THAN ONE YEAR DURATION) IN PATIENTS WHO ARE UNDERGOING OPEN CONCOMITANT CORONARY ARTERY BYPASS GRAFTING AND/OR VALVE REPLACEME
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