| Device Type ID | 2189 |
| Device Name | Implant, Anti-gastroesophageal Reflux |
| 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 | LEI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2189 |
| Device | Implant, Anti-gastroesophageal Reflux |
| Product Code | LEI |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 422 |
Defective Component | 5 |
Detachment Of Device Or Device Component | 5 |
Use Of Device Problem | 3 |
Insufficient Information | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 437 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Torax Medical, Inc. | II | May-31-2018 |