|
Trade Name | THERASPHERE |
Classification Name | microspheres radionuclide |
Generic Name | microspheres radionuclide |
Applicant |
Boston Scientific Corporation |
300 boston scientific way |
marlborough, MA 01752 |
|
HDE Number | H980006 |
Supplement Number | S024 |
Date Received | 03/09/2012 |
Decision Date | 03/29/2012 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for changes in administ111ration set, including replacement with new injection syringe, easily operating tube pinch clamp, and tighten the acceptable radiation range for sterilization to 25-35 gy. , and is indicated for treatment of unresectable hepatocellular carcinoma (hcc). |