LEAD 4965-15 CAPSURE EPI PACING US

LEAD 4965
Capsure® EPI - 4965-15

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium), and the other end is connected to the pacemaker. It may be impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

• Length: 15.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: DTB

Device Name: Permanent Pacemaker Electrode

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3680

Third Party Flag: N

Medical Specialty: CV

Code: NVN

Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Device Class: 3

Physical State: The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a pacemaker or ICD or CRT and the other end applied to the myocardium.

Definition: Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

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

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Makes contact with the heart (myocardial tissue).

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00681490116336

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