NAW · Microspheres Radionuclide
· Class 3
Overview
| Product Code | NAW |
|---|---|
| Device Name | Microspheres Radionuclide |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
Approved PMA: P990065
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200029S011 | TheraSphere | Boston Scientific Corporation | Feb 10, 2026 | APPR |
| P990065S014 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | Jul 1, 2025 | APPR |
| P200029 | TheraSphere | Boston Scientific Corporation | Mar 17, 2021 | APPR |
| P990065 | SIR-SPHERES | Sirtex Medical, Inc. | Mar 5, 2002 | APPR |
Top Applicants
- Boston Scientific Corporation — 2 clearances
- Sirtex Medical, Inc. — 2 clearances
