Product Classification

• Device: drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
• 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.
• 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.
• Technical Method: Used as part of an implantable pacemaker system.
• Target Area: Makes contact with the heart (myocardial tissue).
• Review Panel: Cardiovascular
• Product Code: NVN
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 3-89 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
• 3-125 ISO 5841-3 Third edition 2013-04-15
  Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
• 3-132 ISO 27185 First edition 2012-02-15
  Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
• 3-143 ISO 12417 First edition 2015-10-01
  Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
• 3-185 AAMI ANSI PC76:2021
  Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

Third Party Review

Not Third Party Eligible