Aveir™

Basic Information

• Brand Name: Aveir™
• Primary DI: 05415067040701
• Version / Model: LSP201A
• Catalog Number: LSP201A
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: 5d95d030-1eb1-42fd-82af-607ec3b73bc3

Device Description

Leadless Pacemaker

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNJ	Leadless pacemaker	Cardiovascular	870.3610	3

GMDN Terms

Code	Name	Definition	Implantable	Status
60789	Intracardiac pacemaker	A battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067040701	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P150035	003

Storage Conditions

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