- Physicians Office Resource

LEAD 407485 CAPSURE SENSE US BI RCMCRD
CapSure Sense® - 407485

Device Description

An implantable 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 pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

86.00
59.00

Storage Environment Temperature - Degrees Fahrenheit

77.00
77.00

Device Sizes

Length: 85.0 Centimeter

Length: 85.0 Centimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00643169590540

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

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