Volt™ PFA Sensor Enabled™ A-VOLT-01

GUDID 05415067053022

Catheter

ST. JUDE MEDICAL, INC.

Cardiac irreversible electroporation system catheter

• Primary Device ID: 05415067053022
• NIH Device Record Key: 19b80fe0-68fe-4638-bf9b-f7af76078e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volt™ PFA Sensor Enabled™
• Version Model Number: A-VOLT-01
• Catalog Number: A-VOLT-01
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Length: 107 Centimeter
• Catheter Gauge: 12.5 French
• Length: 107 Centimeter
• Catheter Gauge: 12.5 French
• Length: 107 Centimeter
• Catheter Gauge: 12.5 French
• Length: 107 Centimeter
• Catheter Gauge: 12.5 French

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, protect from heat and radioactive sources
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, protect from heat and radioactive sources
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, protect from heat and radioactive sources
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, protect from heat and radioactive sources

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067053022 [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: true

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

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067051417 - Current™: 2026-01-14 PFA Radiolucent ECG Lead Set
• 05415067051516 - Current™: 2026-01-14 PFA Generator
• 05415067051554 - Current™: 2026-01-14 PFA ECG Trunk Cable
• 05415067051615 - Current™: 2026-01-14 PFA Radiopaque ECG Lead Set
• 05415067051721 - Current™: 2026-01-14 PFA Generator Cart
• 05415067051752 - Current™: 2026-01-14 PFA Generator
• 05415067051813 - Current™: 2026-01-14 PFA Recording System Connect Cable
• 05415067052919 - Current™: 2026-01-14 PFA Catheter Input Module