ICD-VR DVEA3E4 EV ICD EV4 US

ICD
Aurora EV-ICD™ MRI SureScan™ - DVEA3E4

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).

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LWS

Device Name: Implantable Cardioverter Defibrillator (Non-Crt)

Device Class: 3

Physical State: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Definition: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: NVY

Device Name: Permanent Defibrillator Electrodes

Device Class: 3

Physical State: The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to an ICD or CRT-D and the other end located in a position which directs defibrillation energy to the heart

Definition: Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Used as part of an implantable defibrillation system.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Makes contact with the heart (endocardial or myocardial tissue) or is located in a proximity and orientation that creates a vector for defibrillation energy to the heart.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000368470

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A