Product code NAW
- Device name
- Microspheres Radionuclide
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- RA
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Approved PMA: P990065
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990065S019 | SIR-Spheres® Y-90 resin microspheres | Sirtex Medical, Inc. | 2026-05-07 |
| P200029S012 | TheraSphere™ | Boston Scientific Corporation | 2026-04-10 |
| P200029S011 | TheraSphere | Boston Scientific Corporation | 2026-02-10 |
| P990065S014 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | 2025-07-01 |
| P990065S017 | SIR-SPHERES | Sirtex Medical, Inc. | 2025-04-11 |
| P990065S016 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | 2025-01-02 |
| P200029S010 | TheraSphere | Boston Scientific Corporation | 2024-09-24 |
| P200029S009 | TheraSphere | Boston Scientific Corporation | 2024-04-05 |
| P990065S015 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | 2024-03-06 |
| P200029S008 | TheraSphereTM Y-90 Glass Microspheres System | Boston Scientific Corporation | 2024-02-07 |
| P200029S006 | TheraSphere | Boston Scientific Corporation | 2024-02-06 |
| P200029S007 | TheraSphere | Boston Scientific Corporation | 2023-12-18 |
| P990065S013 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | 2023-08-09 |
| P200029S005 | TheraSphere | Boston Scientific Corporation | 2023-07-26 |
| P200029S004 | TheraSphere | Boston Scientific Corporation | 2022-12-02 |
| P990065S012 | SIR-Spheres Y-90 resin microspheres | Sirtex Medical, Inc. | 2022-04-12 |
| P200029S002 | TheraSphere | Boston Scientific Corporation | 2021-08-19 |
| P200029S001 | TheraSphere™ | Boston Scientific Corporation | 2021-05-14 |
| P200029 | TheraSphere | Boston Scientific Corporation | 2021-03-17 |
| P990065S009 | SIR-Spheres microspheres | Sirtex Medical, Inc. | 2017-03-24 |
| P990065S010 | SIR-SPHERES MICROSPHERES | Sirtex Medical, Inc. | 2017-01-18 |
| P990065S008 | SIR-SPHERES MICROSPHERES | Sirtex Medical, Inc. | 2015-02-27 |
| P990065S007 | SIR-SPHERE MICROSPHERES | Sirtex Medical, Inc. | 2014-10-09 |
| P990065S006 | SIR-SPHERES | Sirtex Medical, Inc. | 2012-07-17 |
| P990065S004 | SIR-SPHERES | Sirtex Medical, Inc. | 2008-01-18 |
| P990065S001 | SIR-SPHERES | Sirtex Medical, Inc. | 2003-04-24 |
| P990065 | SIR-SPHERES | Sirtex Medical, Inc. | 2002-03-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00191506025366 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025502 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025496 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025489 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025472 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025465 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025458 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025441 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025434 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025427 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025410 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025403 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025397 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025380 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025373 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025359 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025342 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025335 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025328 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025311 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025304 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025298 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025281 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025274 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025267 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025250 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025243 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025236 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 00191506025229 | TheraSphere™ | BOSTON SCIENTIFIC CORPORATION | 2026-03-01 |
| 05060116920635 | TheraSphere Administration Set | BIOCOMPATIBLES UK LTD | 2018-11-01 |