- Device
- PulseSelect™ Pulsed Field Ablation (PFA) system
- Applicant
- Medtronic, Inc.
- PMA number
- P230017
- Supplement
- S008
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2025-10-08
- Decision code
- OK30
- Date received
- 2025-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the sterilization load configuration for devices sterilized at Sterigenics Columbia City site