Allure™

Basic Information

• Brand Name: Allure™
• Primary DI: 05414734507905
• Version / Model: PM3222
• Catalog Number: PM3222
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-10
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 86259926-7a51-4d82-b7af-5349c15a9411

Device Description

Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47263	Cardiac resynchronization therapy implantable pacemaker	A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734507905	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P030035	108
P030035	151
P030035	153
P030035	154
P030035	175
P030035	177

Device Sizes

Type	Value	Unit	Text
Total Volume	14	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 23 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -5 – 50 Degrees Celsius