FDA.report

Product code QAN

Current FDA Classification

Device name
Stent, Iliac Vein
Medical specialty
Unknown
Device class
3
Review panel
CV
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen

Related PMA Records

PMADeviceApplicantDecision date
P180013S001VICI VENOUS STENT SystemBoston Scientific Corporation2019-10-30
P180013VICI VENOUS STENT SystemBoston Scientific Corporation2019-05-02
P180037Venovo Venous Stent SystemBard Peripheral Vascular, Inc.2019-03-13

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