Aveir™ LSP112V

GUDID 05415067034472

Leadless Pacemaker

ST. JUDE MEDICAL, INC.

Intracardiac pacemaker

• Primary Device ID: 05415067034472
• NIH Device Record Key: 32e41fdc-01cc-4412-8016-c62db89d3d4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveir™
• Version Model Number: LSP112V
• Catalog Number: LSP112V
• 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: 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
• 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

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C). Store at room temperature 25°C (77°F). Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067034472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150035

FDA Product Code

• LWO: Pulse-generator, single chamber, sensor driven, implantable
• PNJ: Leadless pacemaker

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: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [Aveir™]

• 05415067034847: Hydrophilic-Coated Introducer Sheath
• 05415067034823: Hydrophilic-Coated Introducer Sheath
• 05415067036384: Delivery Catheter
• 05415067034496: Retrieval Catheter
• 05415067034472: Leadless Pacemaker
• 05415067031914: Programmer Communication Module
• 05415067038487: Delivery Catheter
• 05415067040725: Leadless Pacemaker
• 05415067040701: Leadless Pacemaker
• 05415067046475: Patient Transmitter
• 05415067046468: Patient Transmitter Wired Electrodes
• 05415067049971: Patient Transmitter Software
• 05415067051189: AR 2 Leadless Pacemaker