PMA P150026S001
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S001
- Product code
- OAE
- Decision date
- 2017-08-03
- 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 to add an alternative supplier and an alternative sterilization process for the Balloon Fill Media.
Current openFDA PMA Record#
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S001
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2017-08-03
- Decision code
- APPR
- Date received
- 2017-05-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add an alternative supplier and an alternative sterilization process for the Balloon Fill Media.