|
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 | S021 |
Date Received | 10/13/2011 |
Decision Date | 01/23/2012 |
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 duplicate manufacturing process in an additional facility within the same building at the manufacturing site. |