Infinity™ 6884

GUDID 05415067055866

Patient Manual and Magnet

ADVANCED NEUROMODULATION SYSTEMS, INC.

Multiple active implantable device programmer

• Primary Device ID: 05415067055866
• NIH Device Record Key: d11762f1-bbc6-4c29-a260-7cb88ca10531
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity™
• Version Model Number: 6884
• Catalog Number: 6884
• Company DUNS: 021675699
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067023988 [Previous]
GS1	05415067055866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140009

FDA Product Code

• PJS: Stimulator, electrical, implanted, for essential tremor

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: 2026-02-23
• Device Publish Date: 2026-02-13

Devices Manufactured by ADVANCED NEUROMODULATION SYSTEMS, INC.

• 05415067055842 - Proclaim™: 2026-02-23 Patient Manual and Magnet
• 05415067055866 - Infinity™: 2026-02-23Patient Manual and Magnet
• 05415067055866 - Infinity™: 2026-02-23 Patient Manual and Magnet
• 05415067053060 - NA: 2025-12-15 DRG Big Curve Delivery Sheath Kit
• 05415067051882 - NA: 2025-04-17 External Pulse Generator, 2 Port Header
• 05415067051899 - NA: 2025-02-03 DBS Charging System
• 05415067051905 - NA: 2025-02-03 SCS Charging System
• 05415067047663 - Liberta RC™: 2024-02-26 Implantable Pulse Generator
• 05415067047670 - NA: 2024-02-26 Charger Kit, Pectoral