PMA P150026S006
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S006
- Product code
- OAE
- Decision date
- 2019-06-24
- 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 a labeling change to add a contraindication.
Current openFDA PMA Record#
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S006
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-06-24
- Decision code
- APPR
- Date received
- 2019-05-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling change to add a contraindication.