Aortic Stent

Device Code: 1083

Product Code(s): PNF

Definition: Coarctation Of The Aorta

Device Classification Information

Device Type ID1083
Device NameAortic Stent
Physical StateThe Stent Is Metal And Is Offered In A Range Of Diameters
Technical MethodAn Expandable Stent Is Placed In The Aorta To Keep The Vessel Open
Target AreaAorta
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodePNF
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1083
DeviceAortic Stent
Product CodePNF
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 19:48:09

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