Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150026/s008.
| Device | HeartLight Catheter and HeartLight Console |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | CARDIOFOCUS, INC. |
| Date Received | 2020-06-01 |
| Decision Date | 2020-07-01 |
| PMA | P150026 |
| Supplement | S011 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752 |
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