Product Classification

• Device: materials, repair or replacement, pacemaker
• Regulation Description: Pacemaker repair or replacement material.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: KFJ
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: PMA
• Regulation Number: 870.3710
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 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