Definition: PMA Approved: P010020
| Device Type ID | 2210 |
| Device Name | Implanted Fecal Incontinence Device |
| 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 | MIP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2210 |
| Device | Implanted Fecal Incontinence Device |
| Product Code | MIP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Fluid Leak | 4 |
Insufficient Information | 3 |
Cuff | 3 |
Mechanical Problem | 2 |
Leak / Splash | 2 |
Inadequacy Of Device Shape And/or Size | 1 |
Failure Of Device To Self-Test | 1 |
Material Deformation | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 26 |