|
Device | TheraSphere |
Generic Name | Microspheres radionuclide |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P200029 |
Supplement Number | S007 |
Date Received | 11/27/2023 |
Decision Date | 12/18/2023 |
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 the manufacturing change to allow the ball mill to be used as an optional alternative to the mortar and pestle in the final frit crushing step. |