Pulse-generator, Single Chamber, Sensor Driven, Implantable

Device Code: 1011

Product Code(s): LWO

Device Classification Information

• Device Type ID: 1011
• Device Name: Pulse-generator, Single Chamber, Sensor Driven, Implantable
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LWO
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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

Total Product Life Cycle

• Device Type ID: 1011
• Device: Pulse-generator, Single Chamber, Sensor Driven, Implantable
• Product Code: LWO
• FDA Device Classification: Class 3 Medical Device

Device Problems
Pacing Problem	4
Failure To Interrogate	2
Decreased Sensitivity	1
Premature Discharge Of Battery	1
Appropriate Term/Code Not Available	1
Failure To Capture	1
Inappropriate Shock	1
Battery Problem	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Total Device Problems	13

TPLC Last Update: 2019-04-02 19:46:20