| Device Type ID | 2195 |
| Device Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LNM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2195 |
| Device | Agent, Bulking, Injectable For Gastro-urology Use |
| Product Code | LNM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 210 |
Appropriate Term/Code Not Available | 11 |
Migration Or Expulsion Of Device | 4 |
Improper Or Incorrect Procedure Or Method | 3 |
No Apparent Adverse Event | 3 |
Patient-Device Incompatibility | 2 |
Calcified | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Insufficient Information | 2 |
Shelf Life Exceeded | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 241 |