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Trade Name | MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES |
Classification Name | microspheres radionuclide |
Generic Name | microspheres radionuclide |
Applicant |
Boston Scientific Corporation |
300 boston scientific way |
marlborough, MA 01752 |
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HDE Number | H980006 |
Supplement Number | S006 |
Date Received | 12/17/2003 |
Decision Date | 01/09/2004 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | 30-day notice |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in administration set for the therasphere yttrium-90 microspheres to be manufacturered with the needles approved in supplement 5 and withoutredundant syringe. |