Definition: PMAs To Be Filed By 7/11/00 (65 FR 19658 (4/12/00))
| Device Type ID | 1847 |
| Device Name | Device, Impotence, Mechanical/hydraulic |
| Regulation Description | Penile Inflatable Implant. |
| 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 | 876.3350 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FHW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1847 |
| Device | Device, Impotence, Mechanical/hydraulic |
| Product Code | FHW |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Penile Inflatable Implant. |
| CFR Regulation Number | 876.3350 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 751 |
Fluid Leak | 371 |
Inflation Problem | 337 |
Mechanical Problem | 213 |
Break | 103 |
Material Puncture / Hole | 100 |
Inadequacy Of Device Shape And/or Size | 89 |
Defective Device | 86 |
Leak / Splash | 78 |
Migration | 64 |
Deflation Problem | 56 |
Degraded | 40 |
Material Rupture | 38 |
Pumping Problem | 35 |
Device Inoperable | 35 |
Fracture | 34 |
Malposition Of Device | 31 |
Failure To Cycle | 28 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Material Deformation | 22 |
Material Protrusion / Extrusion | 18 |
Collapse | 17 |
Migration Or Expulsion Of Device | 17 |
Use Of Device Problem | 16 |
Positioning Problem | 14 |
Infusion Or Flow Problem | 10 |
Cylinder | 8 |
Pump | 7 |
Gas Leak | 7 |
Device Operates Differently Than Expected | 7 |
Hole In Material | 6 |
Free Or Unrestricted Flow | 6 |
Extrusion | 5 |
Connection Problem | 4 |
Crack | 4 |
Torn Material | 3 |
Deformation Due To Compressive Stress | 3 |
Material Frayed | 2 |
Reservoir | 1 |
Structural Problem | 1 |
Device Operational Issue | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Contamination During Use | 1 |
Device Appears To Trigger Rejection | 1 |
Detachment Of Device Or Device Component | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Device Slipped | 1 |
Material Perforation | 1 |
Cut In Material | 1 |
Device Markings / Labelling Problem | 1 |
Short Fill | 1 |
Difficult Or Delayed Activation | 1 |
Entrapment Of Device | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Mechanical Jam | 1 |
Material Fragmentation | 1 |
Tube | 1 |
Decrease In Pressure | 1 |
| Total Device Problems | 2715 |