LEAD 439888 MRI STRAIGHT US

LEAD 439888 MRI STRAIGHT US
Attain Performa™ Straight MRI SureScan™ - 439888

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.

• Length: 88.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OJX

Device Name: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Device Class: 3

Physical State: The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a CRT device and the other end located in a left cardiac vein.

Definition: Drug eluting permanent lv pacemaker electrodes are used with compatible 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 crt system.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Makes contact with the lv via the left cardiac vein.

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

Device Id: 00643169601857

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