This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | AtriCure Synergy Ablation System |
| Generic Name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Applicant | ATRICURE INC.7555 Innovation Waymason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-11-15 |
| PMA | P100046 |
| Supplement | S013 |
| Product Code | OCM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ATRICURE INC. 7555 Innovation Way mason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The AtriCure Multifunctional Ablation Generator (MAG) As Part Of The Synergy Ablation System For Use With The Isolator® Synergy Clamp™ (OLL2 And OSL2). |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00818354010596 | P100046 | 003 |
| 00818354010558 | P100046 | 003 |
| 00818354010503 | P100046 | 003 |
| 00818354010206 | P100046 | 003 |
| 30840143902318 | P100046 | 003 |
| 30840143902141 | P100046 | 003 |
| 30840143903018 | P100046 | 003 |