TheraSphere

FDA premarket approval P200029 · Microspheres radionuclide

PMA numberP200029

Approval

Applicant
Boston Scientific Corporation
Received
June 24, 2020
Decision date
March 17, 2021 (APPR)
Supplements
13, latest August 21, 2026
Product code
NAW – Microspheres Radionuclide

Official FDA PMA record

Approval order 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.