PMA P240013S010
- Device
- Sphere-9™ Mapping and Ablation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S010
- Product code
- QZI
- Decision date
- 2025-09-04
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- approval for modifications to the catheter packaging
Current openFDA PMA Record#
- Device
- Sphere-9™ Mapping and Ablation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S010
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2025-09-04
- Decision code
- APPR
- Date received
- 2025-06-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for modifications to the catheter packaging