Definition: PMA To Be Filed By 12/26/00 (65 FR 57731 (9/26/00))
| Device Type ID | 1717 |
| Device Name | Device, Incontinence, Mechanical/hydraulic |
| Regulation Description | Implanted Mechanical/hydraulic Urinary Continence Device. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 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 |
| CFR Regulation Number | 876.5280 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | EZY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1717 |
| Device | Device, Incontinence, Mechanical/hydraulic |
| Product Code | EZY |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Implanted Mechanical/hydraulic Urinary Continence Device. |
| CFR Regulation Number | 876.5280 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 936 |
Fluid Leak | 228 |
Mechanical Problem | 66 |
Inadequacy Of Device Shape And/or Size | 57 |
Material Puncture / Hole | 57 |
Adverse Event Without Identified Device Or Use Problem | 31 |
Migration | 21 |
Appropriate Term/Code Not Available | 19 |
Defective Device | 19 |
Failure To Cycle | 15 |
Malposition Of Device | 13 |
Decrease In Pressure | 9 |
Gas Leak | 4 |
Inflation Problem | 3 |
Unstable | 3 |
Use Of Device Problem | 3 |
Self-Activation Or Keying | 3 |
Balloon | 3 |
Connection Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Material Deformation | 2 |
Pump | 2 |
Difficult Or Delayed Activation | 2 |
Material Erosion | 1 |
Pacing Problem | 1 |
Tube | 1 |
Device Sensing Problem | 1 |
Failure To Capture | 1 |
Material Discolored | 1 |
Over-Sensing | 1 |
Product Quality Problem | 1 |
Extrusion | 1 |
Cuff | 1 |
Premature Discharge Of Battery | 1 |
High Impedance | 1 |
Increase In Pressure | 1 |
Device Dislodged Or Dislocated | 1 |
Activation Problem | 1 |
Deflation Problem | 1 |
| Total Device Problems | 1516 |