PMA P230017S011
- Device
- PulseSelect Pulse Field Ablation (PFA) Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P230017
- Supplement
- S011
- Product code
- QZI
- Decision date
- 2026-06-30
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- addition of an alternative sterilization site
Current openFDA PMA Record#
- Device
- PulseSelect Pulse Field Ablation (PFA) Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P230017
- Supplement
- S011
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-06-30
- Decision code
- OK30
- Date received
- 2026-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternative sterilization site