- Device
- Sphere-9 Catheter (AFR-00001)
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S020
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a manufacturing process change to the flux material used to solder catheter wires.