LEAD 6721L
NA - 6721L-50
Device Description
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.
Environmental Conditions
- 104.00
- N/A
Device Sizes
- Length: 50.0 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: 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
Device IdentifiersDevice Id: 00681490148733
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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