- Device
- PulseSelect Pulse Field Ablation (PFA) Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P230017
- Supplement
- S010
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-04-13
- Decision code
- APPR
- Date received
- 2026-03-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Parkmore Business Park, West, Ballybrit, Galway, Ireland