Product code NIV

Device name

Coronary Covered Stent

Medical specialty

Unknown

Device class

f

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.

Source

FDA openFDA device classification dataset