Pulse Generator, External Pacemaker, Dual Chamber

Device Code: 956

Product Code(s): OVJ

Definition: A Dual Chamber External Pacemaker Is Intended To Provide Temporary Dual Chamber Cardiac Pacing As A Substitute For The Heart's Intrinsic Pacing System Until A Permanent Pacemaker Can Be Implanted, Or To Control Irregular Heartbeats Following Cardiac

Device Classification Information

• Device Type ID: 956
• Device Name: Pulse Generator, External Pacemaker, Dual Chamber
• Physical State: A System Generally Includes The Pulse Generator, Extension Cables, And Adaptors. The Pulse Generator Has A Power Supply And Electronic Components Capable Of Data Input, Data Output, And Data Processing.
• Technical Method: The Device Is Used With Either An Endocardial (transluminal) Or Epicardial Cardiac Pacing Leads System To Deliver A Period Electrical Pulse Which Stimulates The Heart.
• Target Area: This Device Is Used In The Right Atrium And Right Ventricle Only.
• Regulation Description: External Pacemaker Pulse Generator.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.3600 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OVJ
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-102 IEC 60601-2-31 Edition 2.1 2011-09
  Medical Electrical Equipment, Part 2-31: Particular Requirements For The Basic Safety And Essential Performance Of External Cardiac Pacemakers With Internal Power Source
• 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

Total Product Life Cycle

• Device Type ID: 956
• Device: Pulse Generator, External Pacemaker, Dual Chamber
• Product Code: OVJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: External Pacemaker Pulse Generator.
• CFR Regulation Number: 870.3600 [🔎]

Device Problems
No Pacing	7
Pacing Problem	6
Blocked Connection	2
Failure To Power Up	2
Pacemaker Found In Back-Up Mode	1
Insufficient Information	1
Premature Discharge Of Battery	1
Adverse Event Without Identified Device Or Use Problem	1
Failure To Capture	1
Device Sensing Problem	1
Total Device Problems	23

TPLC Last Update: 2019-04-02 19:45:26