PMA P240013S027

Device: Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension Cable
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S027
Product code: QZI
Decision date: 2026-05-13
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: to add of a 10-pallet sterilization chamber at the sterilizer contractor, Professional Contract Sterilization, Inc. (PCS) located in Taunton, MA

Current openFDA PMA Record#

Device: Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension Cable
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S027
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-05-13
Decision code: OK30
Date received: 2026-04-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add of a 10-pallet sterilization chamber at the sterilizer contractor, Professional Contract Sterilization, Inc. (PCS) located in Taunton, MA