Product Classification

• Device: electrode, pacemaker, temporary
• Regulation Description: Cardiovascular permanent or temporary pacemaker electrode.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: LDF
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.3680
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 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
• 3-185 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