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Trade Name | THERASPHERE IDOC, 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 | S032 |
Date Received | 07/16/2015 |
Decision Date | 09/14/2015 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the introduction of therasphere® idoctm, a standalone software tool to assist in the ordering of therasphere® y-90 glass microspheres dose vials. |