Accent® PM2210

GUDID H758PM221001

Pulse Generator DDDR

ST. JUDE MEDICAL, INC.

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive

• Primary Device ID: H758PM221001
• NIH Device Record Key: c6e91161-8fed-4846-9be4-a018778a1798
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accent®
• Version Model Number: DR RF
• Catalog Number: PM2210
• Company DUNS: 790268031
• 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: 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

Device Dimensions

• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter
• Total Volume: 12.9 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734503617 [Primary]
HIBCC	H758PM221001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880086

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-10-23

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