|
Device | ATRICURE SYNERGY ABLATION SYSTEM |
Generic Name | Surgical cardiac ablation device, for treatment of atrial fibrillation |
Applicant | ATRICURE INC. 7555 Innovation Way Mason, OH 45040 |
PMA Number | P100046 |
Date Received | 12/23/2010 |
Decision Date | 12/14/2011 |
Product Code |
OCM |
Docket Number | 11M-0910 |
Notice Date | 12/19/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00560885
|
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order 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 REPLACEMENT OR REPAIR. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S015 S016 S017 S018 |