System, Laser, Transmyocardial Revascularization

Device Code: 1032

Product Code(s): MNO

Device Classification Information

• Device Type ID: 1032
• Device Name: System, Laser, Transmyocardial Revascularization
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Electrophysiology Devices Branch (CEDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MNO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-268 IEC 60601-2-22 Edition 3.1 2012-10
  Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• 12-273 IEC 60825-1 Edition 2.0 2007-03
  Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Total Product Life Cycle

• Device Type ID: 1032
• Device: System, Laser, Transmyocardial Revascularization
• Product Code: MNO
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	16
Break	3
Crack	2
Difficult To Advance	2
Appropriate Term/Code Not Available	2
Material Frayed	1
Failure To Fire	1
Thermal Decomposition Of Device	1
Calibration Error	1
Charred	1
Loss Of Power	1
Total Device Problems	31

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