Device Type ID | 4123 |
Device Name | Stent, Bladder, Fetal |
Review Panel | Obstetrics/Gynecology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
Submission Type | HDE - Humanitarian Device Exem |
FDA Device Classification | Class HDE Medical Device |
Product Code | MPR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4123 |
Device | Stent, Bladder, Fetal |
Product Code | MPR |
Device Problems | |
---|---|
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Bent | 1 |
Total Device Problems | 2 |