Addition of a visual inspection for proximal weld length for the devices, modifications relating to the laser welder for distal and proximal jaw weldments and the addition of a re-welding process for the oll2 and osl2 proximal and distal weldments.
| Device | ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB |
| 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 | 2013-05-13 |
| Decision Date | 2013-06-14 |
| PMA | P100046 |
| Supplement | S002 |
| Product Code | OCM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ATRICURE INC. 7555 Innovation Way mason, OH 45040 |
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