|
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 | S025 |
Date Received | 07/11/2012 |
Decision Date | 09/11/2012 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of mo-sci corporation, a glass product manufacturer, as second manufacturer of raw materials (glass frit) for production of y-90 glass microspheres. Allvalidation tests for quality product have been tested and passed. |