PMA P150026S008
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- Product code
- OAE
- Decision date
- 2020-05-08
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for the HeartLight X3 Endoscopic Ablation System.
Current openFDA PMA Record#
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S008
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-05-08
- Decision code
- APPR
- Date received
- 2019-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the HeartLight X3 Endoscopic Ablation System.