TheraSphere
FDA premarket approval P200029 · decided 2021-03-17
Approval details
- PMA number
- P200029
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-06-24
- Decision date
- 2021-03-17
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for TheraSphereTM. This device is indicated for use as selective internal radiation therapy (SIRT) for local tumor control of solitary tumors (1-8 cm in diameter), in patients with unresectable hepatocellular carcinoma (HCC), Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |