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.
| Device | ATRICURE SYNERGY ABLATION SYSTEM |
| Classification Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Generic Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Applicant | ATRICURE INC. |
| Date Received | 2010-12-23 |
| Decision Date | 2011-12-14 |
| Notice Date | 2011-12-19 |
| PMA | P100046 |
| Supplement | S |
| Product Code | OCM |
| Docket Number | 11M-0910 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ATRICURE INC. 7555 Innovation Way mason, OH 45040 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100046 | | Original Filing |
| S013 |
2022-03-01 |
Normal 180 Day Track |
| S012 |
2020-08-03 |
30-day Notice |
| S011 | | |
| S010 |
2018-12-28 |
Normal 180 Day Track No User Fee |
| S009 |
2018-12-10 |
30-day Notice |
| S008 |
2016-09-01 |
30-day Notice |
| S007 |
2016-06-22 |
Normal 180 Day Track No User Fee |
| S006 |
2014-11-21 |
Real-time Process |
| S005 |
2014-05-21 |
Normal 180 Day Track No User Fee |
| S004 |
2014-04-15 |
Normal 180 Day Track No User Fee |
| S003 |
2013-07-12 |
Normal 180 Day Track |
| S002 |
2013-05-13 |
30-day Notice |
| S001 |
2012-02-14 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices