Definition: Approved PMA: P990065
| Device Type ID | 5442 |
| Device Name | Microspheres Radionuclide |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NAW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5442 |
| Device | Microspheres Radionuclide |
| Product Code | NAW |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 66 |
Insufficient Information | 5 |
Patient-Device Incompatibility | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Inadequate Instructions For Healthcare Professional | 1 |
Activation, Positioning Or Separation Problem | 1 |
Malposition Of Device | 1 |
Radiation Underexposure | 1 |
| Total Device Problems | 80 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biocompatibles U.K., Ltd. | II | Oct-13-2016 |