Product Classification

• Device: pulse generator, permanent, implantable
• Definition: Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
• Physical State: A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).
• Technical Method: Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.
• Target Area: Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.
• Review Panel: Cardiovascular
• Product Code: NVZ
• 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

• 3-110 AAMI TIR 41:2011/(R)2017
  Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
• 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
• 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