Prodigy MRI™ 3772

GUDID 05415067017093

IPG, 16 CH, Rechargeable

ST. JUDE MEDICAL, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 05415067017093
• NIH Device Record Key: 77d45167-7fcd-4a46-839f-d89e333412d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy MRI™
• Version Model Number: 3772
• Catalog Number: 3772
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
• 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
• 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
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067017093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010032

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• MHY: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-01

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• 05415067053145 - EnSite™: 2025-04-11 X EP System PFA Catheter Visualization Temporary Software License
• 05415067050045 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050052 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050076 - Neutrino™: 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050090 - Gallant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
• 05415067050106 - Entrant™: 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV