PMA P240013

Device: Affera Sphere-9 Mapping and Ablation Catheter
Applicant: Medtronic, Inc.
Product code: QZI
Decision date: 2026-10-09
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: an alternative to batch testing for bacterial endotoxin testing (BET)

Current openFDA PMA Record#

Device: Affera Sphere-9 Mapping and Ablation Catheter
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S032
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-10-09
Decision code: OK30
Date received: 2026-09-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative to batch testing for bacterial endotoxin testing (BET)