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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 | S002 |
Date Received | 02/15/2001 |
Decision Date | 03/06/2001 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Increase in the quantity of glass microspheres to be irradiated from 1. 5g to 2. 5g to accommodate production scale-up. |