Product Classification

• Device: leadless pacemaker
• Regulation Description: Implantable pacemaker pulse generator.
• Definition: To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
• Physical State: TBD
• Technical Method: TBD
• Target Area: TBD
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: PNJ
• Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: PMA
• Regulation Number: 870.3610
• 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

• 3-185 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
• 13-146 IEEE 11073-10103 Second edition 2023
  Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac

Third Party Review

Not Third Party Eligible