Product Classification

• Device: defibrillator, implantable, dual-chamber
• Review Panel: Cardiovascular
• Product Code: MRM
• 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

• 3-63 ISO 11318:2002
  Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
• 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
• 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