|
Trade Name | THERASPHERE |
Classification Name | microspheres radionuclide |
Generic Name | microspheres radionuclide |
Applicant |
Boston Scientific Corporation |
300 boston scientific way |
marlborough, MA 01752 |
|
HDE Number | H980006 |
Supplement Number | S029 |
Date Received | 12/03/2014 |
Decision Date | 03/18/2015 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a new manufacturing suite in the samebuilding as the two existing manufacturing suites at nordion (canada) inc, ottawa, ontario, canada. |