PMA P200029S011

Device: TheraSphere
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S011
Product code: NAW
Decision date: 2026-02-10
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: TheraSphere are indicated for use as selective internal radiation therapy (SIRT) for local tumor control of solitary tumors (1-8 cm diameter), in patients with unresectable hepatocellular carcinoma (HCC), Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.

Current openFDA PMA Record#

Device: TheraSphere
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S011
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2026-02-10
Decision code: APPR
Date received: 2024-09-20
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: TheraSphere are indicated for use as selective internal radiation therapy (SIRT) for local tumor control of solitary tumors (1-8 cm diameter), in patients with unresectable hepatocellular carcinoma (HCC), Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.