EMBLEM™ S-ICD Electrode Delivery System

Basic Information

• Brand Name: EMBLEM™ S-ICD Electrode Delivery System
• Primary DI: 00802526591907
• Version / Model: 4712
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-29
• Public Version: 3
• Public Version Date: 2022-01-14
• Public Version Status: Update
• Public Device Record Key: 0993664e-3e6f-40ad-abbb-b76c716debe7

Device Description

Electrode Delivery System

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: No
• Has Lot/Batch Number: Yes
• 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
LWS	Implantable cardioverter defibrillator (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60956	Pacing/defibrillation lead tunneller	A sterile hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It is a long, thin, semi-flexible rod with a rounded distal tip and a handle at the proximal end to allow the surgeon to push through body tissues; it may include an integrated sheath (e.g., split sheath) intended to assist lead placement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526591907	GS1

Premarket Submissions

Submission Number	Supplement Number
P110042	102
P110042	132
P110042	164