FDA Premarket Approval P200029

Pre-market Approval Supplement Details

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.

Generic NameMicrospheres Radionuclide
ApplicantBoston Scientific Corporation
Date Received2020-06-24
Decision Date2021-03-17
Product CodeNAW 
Advisory CommitteeRadiology
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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Supplement NumberDateSupplement Type
P200029Original Filing

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