Product Classification

• Device: permanent defibrillator electrodes
• 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.
• 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
• Technical Method: Used as part of an implantable defibrillation system.
• 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.
• Review Panel: Cardiovascular
• Product Code: NVY
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 5841-3:2000 Technical Corrigendum 1 2003-11-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers, Technical Corrigendum 1
• ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
• AAMI/ANSI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
• ISO 5841-3 Second edition 2000-10-15 Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers

Third Party Review

Not Third Party Eligible