Product Classification

• Device: atrial defibrillator
• Regulation Description: DC-defibrillator (including paddles).
• Definition: Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: MPC
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: PMA
• Regulation Number: 870.5300
• 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

• 3-129 ANSI AAMI EC53:2013/(R)2020
  ECG trunk cables and patient leadwires
• 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