PMA P240013S031
- Device
- Sphere-9 Catheter and Affera Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S031
- Product code
- QZI
- Decision date
- 2026-10-02
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- for changes to the instructions for use (IFU)
Current openFDA PMA Record#
- Device
- Sphere-9 Catheter and Affera Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S031
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-10-02
- Decision code
- APPR
- Date received
- 2026-08-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- for changes to the instructions for use (IFU)