Stent, Urethral, Prostatic, Permanent Or Semi-permanent

Device Code: 2207

Product Code(s): MER

Device Classification Information

Device Type ID2207
Device NameStent, Urethral, Prostatic, Permanent Or Semi-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 CodeMER
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2207
DeviceStent, Urethral, Prostatic, Permanent Or Semi-permanent
Product CodeMER
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:07:45

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