Approval for the heartlight endoscopic ablation system with excalibur balloon, which represents design and labeling changes to the heartlight endoscopic ablation system, including changes to the balloon component and cooling loop, and the addition of a balloon remote.
| Device | Heart Light Catheter with Excalibur Balloon |
| 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 | 2017-08-09 |
| Decision Date | 2018-05-02 |
| PMA | P150026 |
| Supplement | S002 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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