|
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 |
|
HDE Number | H980006 |
Supplement Number | S012 |
Date Received | 11/28/2006 |
Decision Date | 02/16/2007 |
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 a change in construction of cover plate on the dose k vial in order to prevent leakage, changes in package insert to include an additional adverse event,a new adverse event table, deleting an obsolete imaging modality from the list of required procedures in the preliminary patient evaluation, and other minor changes to provide improved description of the infusion assembly. |