PMA P150026S004
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S004
- Product code
- OAE
- Decision date
- 2018-04-16
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Implement an automated label printing system for UDI requirements.
Current openFDA PMA Record#
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S004
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-04-16
- Decision code
- OK30
- Date received
- 2018-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an automated label printing system for UDI requirements.