|
Device | TheraSphere |
Generic Name | Microspheres radionuclide |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P200029 |
Supplement Number | S005 |
Date Received | 06/26/2023 |
Decision Date | 07/26/2023 |
Product Code |
NAW |
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 Supplier changes within the production of Loctite 4307 which is used in the manufacturing of the TheraSphere Administration Set manufactured by CEA. |