LEAD 6935100 SPRINT US RCMCRD

LEAD 6935100 SPRINT US RCMCRD
Sprint Quattro Secure S™ - 6935100

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

• Length: 100.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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: 00763000180034

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