Heartlight Endoscopic Ablation System
FDA premarket approval P150026 · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA numberP150026
Approval
- Applicant
- Cardiofocus, Inc.
- Received
- July 30, 2015
- Decision date
- April 1, 2016 (APPR)
- Supplements
- 15, latest August 11, 2023
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approval order statement
The HeartLight® Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation