The heartlight® endoscopic ablation system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation
| Device | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | CARDIOFOCUS, INC. |
| Date Received | 2015-07-30 |
| Decision Date | 2016-04-01 |
| Notice Date | 2016-04-12 |
| PMA | P150026 |
| Supplement | S |
| Product Code | OAE |
| Docket Number | 16M-1124 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752 |
| 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 |
|---|
| P150026 | | Original Filing |
| S013 |
2022-03-04 |
Normal 180 Day Track |
| S012 |
2021-01-06 |
Normal 180 Day Track |
| S011 |
2020-06-01 |
Normal 180 Day Track No User Fee |
| S010 |
2020-01-22 |
30-day Notice |
| S009 |
2019-12-18 |
30-day Notice |
| S008 | | |
| S007 |
2019-08-13 |
Real-time Process |
| S006 |
2019-05-29 |
Special (immediate Track) |
| S005 |
2019-01-08 |
Normal 180 Day Track |
| S004 |
2018-04-04 |
30-day Notice |
| S003 |
2017-11-09 |
Real-time Process |
| S002 |
2017-08-09 |
Normal 180 Day Track |
| S001 |
2017-05-05 |
Real-time Process |
NIH GUDID Devices