PMA P150026S002
- Device
- Heart Light Catheter with Excalibur Balloon
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S002
- Product code
- OAE
- Decision date
- 2018-05-02
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- Heart Light Catheter with Excalibur Balloon
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S002
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-05-02
- Decision code
- APPR
- Date received
- 2017-08-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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.