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.
Device | TheraSphere |
Generic Name | Microspheres Radionuclide |
Applicant | Boston Scientific Corporation |
Date Received | 2020-06-24 |
Decision Date | 2021-03-17 |
PMA | P200029 |
Supplement | S |
Product Code | NAW |
Advisory Committee | Radiology |
Expedited Review | No |
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 |
Supplement Number | Date | Supplement Type |
---|---|---|
P200029 | Original Filing | |
S004 | 2022-11-02 | Normal 180 Day Track No User Fee |
S003 | ||
S002 | 2021-07-22 | Real-time Process |
S001 | 2021-04-15 | Normal 180 Day Track No User Fee |