- Device
- Sphere-9 Catheter and Affera Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S025
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-05-15
- Decision code
- APPR
- Date received
- 2026-04-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new contract manufacturer, a new sterilization site, and a new packaging configuration and material (along with suppliers) for Catheter Extension Cable (Model AFR 00006)