Stent, Urethral, External Sphincter, Permanent

Device Code: 2214

Product Code(s): MXQ

Device Classification Information

Device Type ID2214
Device NameStent, Urethral, External Sphincter, Permanent
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMXQ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2214
DeviceStent, Urethral, External Sphincter, Permanent
Product CodeMXQ
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:07:51

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