EMBLEM™ S-ICD

Basic Information

• Brand Name: EMBLEM™ S-ICD
• Primary DI: 00802526544101
• Version / Model: A209
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 106295384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-26
• Public Version: 10
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: 85c6f20c-9303-45e7-b82a-ce07757062f4

Device Description

Subcutaneous Implantable Cardioverter Defibrillator

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: 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
LWS	Implantable cardioverter defibrillator (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35852	Single-chamber implantable defibrillator	An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526544101	GS1

Premarket Submissions

Submission Number	Supplement Number
P110042	043
P110042	058
P110042	060
P110042	080
P110042	088
P110042	102
P110042	123
P110042	132
P110042	143
P110042	164
P110042	174
P110042	181