|
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 | S026 |
Date Received | 11/12/2013 |
Decision Date | 01/24/2014 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at the national research universal (nru) reactor run by atomic energy of canada ltd. In chalk river, ontario. |