|
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 | S034 |
Date Received | 10/05/2016 |
Decision Date | 12/12/2016 |
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 an addition of the australian nuclear science and technology organization (ansto) with the open pool australian ligh-water (opal) research nuclear reactor, located at lucas height, new south wales, australia to currently approved 3 other nuclear reactor to irradiate y-89 in the therasphere ampules to convert into y-90 beta emitting radioisotopes. |