FARASTAR™

Basic Information

• Brand Name: FARASTAR™
• Primary DI: 00191506042882
• Version / Model: M004PF61M401
• Catalog Number: M004PF61M401
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-09
• Public Version: 1
• Public Version Date: 2024-02-19
• Public Version Status: New
• Public Device Record Key: a156c4b3-cfa3-4203-a015-7b8949177b4c

Device Description

Pulsed Field Ablation Generator

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QZI	Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
65067	Cardiac irreversible electroporation system generator	A cardiac-dedicated mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation (a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death) for the selective nonthermal ablation of cardiac tissues. It includes controls (e.g., foot-switch), user interface, and is designed to connect to appropriate cardiac mapping equipment and catheter (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191506042882	GS1

Premarket Submissions

Submission Number	Supplement Number
P230030	000