|
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 | S003 |
Date Received | 06/20/2001 |
Decision Date | 07/12/2001 |
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 Inclusion of the monarch inflation syringe in the therasphere administration kit. |