System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

Device Code: 1038

Product Code(s): MTE

Device Classification Information

• Device Type ID: 1038
• Device Name: System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
• 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: MTE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 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: 1038
• Device: System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
• Product Code: MTE
• FDA Device Classification: Class 3 Medical Device

Device Problems
Difficult To Advance	1
Failure To Deliver Shock	1
Difficult To Position	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 19:47:08