TheraSphere™ – P200029 | 合法醫療器材資訊網

2021年4月6日—Whatisit?TheraSphereisaradiationtreatmentforpeoplewhohaveaspecifictypeoflivercancercalledunresectablehepatocellularcarcinoma ...

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: TheraSphere™ PMA Applicant: Boston Scientific Corporation Address: 11 Hines Road, Suite 200, Ottawa, CAN K2K 2X1 Ontario Approval Date: March 17, 2021 Approval Letter: Approval Letter[1]

TheraSphere is a radiation treatment for people who have a specific type of liver cancer called unresectable hepatocellular carcinoma (HCC). TheraSphere consists of millions of microscopic glass spheres containing yttrium-90. Yttrium-90 is used in radiation therapy to treat ce...