Device. Laser Peripheral Angioplasty

Device Code: 1018

Product Code(s): LWX

Device Classification Information

Device Type ID1018
Device NameDevice. Laser Peripheral Angioplasty
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLWX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1018
DeviceDevice. Laser Peripheral Angioplasty
Product CodeLWX
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 19:46:39

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