Current™ PFA-GEN-V101

GUDID 05415067053886

PFA Generator Software Upgrade

ST. JUDE MEDICAL, INC.

Cardiac irreversible electroporation system generator

• Primary Device ID: 05415067053886
• NIH Device Record Key: b37f97c6-bfcf-49d2-b162-64dde73e2452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Current™
• Version Model Number: PFA-GEN-V101
• Catalog Number: PFA-GEN-V101
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.Protect from heat and radioactive sources.
• Handling Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067053886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250022

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-14
• Device Publish Date: 2026-01-06

On-Brand Devices [Current™]

• 05414734503723: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734503716: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734503709: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734503686: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05415067053886: PFA Generator Software Upgrade
• 05415067052919: PFA Catheter Input Module
• 05415067051813: PFA Recording System Connect Cable
• 05415067051752: PFA Generator
• 05415067051721: PFA Generator Cart
• 05415067051615: PFA Radiopaque ECG Lead Set
• 05415067051554: PFA ECG Trunk Cable
• 05415067051516: PFA Generator
• 05415067051417: PFA Radiolucent ECG Lead Set