Device Type ID | 2214 |
Device Name | Stent, Urethral, External Sphincter, Permanent |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MXQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2214 |
Device | Stent, Urethral, External Sphincter, Permanent |
Product Code | MXQ |
FDA Device Classification | Class 3 Medical Device |