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 |
|---|---|---|---|
| P200029S013 | TheraSphere™ Y-90 Glass Microspheres System | Boston Scientific Corporation | 2026-06-04 |
| 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 |
|---|---|---|---|
| 05060116921502 | TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921649 | TheraSphere Y90 Glass Microspheres 16.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921632 | TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921625 | TheraSphere Y90 Glass Microspheres 15.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921618 | TheraSphere Y90 Glass Microspheres 15.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921601 | TheraSphere Y90 Glass Microspheres 14.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921595 | TheraSphere Y90 Glass Microspheres 14.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921588 | TheraSphere Y90 Glass Microspheres 13.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921571 | TheraSphere Y90 Glass Microspheres 13.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921564 | TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921557 | TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921540 | TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921533 | TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921526 | TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921519 | TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921496 | TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921489 | TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921472 | TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921465 | TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921458 | TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921441 | TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921434 | TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921427 | TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921410 | TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921403 | TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921397 | TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921380 | TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116921373 | TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) | BIOCOMPATIBLES UK LTD | 2020-06-19 |
| 05060116920635 | TheraSphere Administration Set | BIOCOMPATIBLES UK LTD | 2018-11-01 |
| 05060116920253 | TheraSphere Administration Set | BIOCOMPATIBLES UK LTD | 2014-09-24 |