Definition: Percutaneous Gastric Implant To Remove Stomach Contents After Eating For Weight Loss In The Treatment Of Obesity In Adults
| Device Type ID | 2224 |
| Device Name | Aspiration Therapy System |
| Physical State | PEG Tube Made Of Plastic |
| Technical Method | Percutaneous Implantation |
| Target Area | Stomach |
| 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 | OYF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2224 |
| Device | Aspiration Therapy System |
| Product Code | OYF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Material Separation | 2 |
Cut In Material | 1 |
Torn Material | 1 |
Material Split, Cut Or Torn | 1 |
| Total Device Problems | 5 |