|
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 | S030 |
Date Received | 03/09/2015 |
Decision Date | 03/30/2015 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Increase the amount of mass to be irradiated and dispensed from ampoules processed at the missouri university research reactor (murr) for therasphere®, yttrium-90 glass microspheres. |