- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S009
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2024-04-05
- Decision code
- OK30
- Date received
- 2024-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to enhance the criteria for visual sampling and inspection of the TheraSphere Administration Sets manufactured by B. Braun Medical Inc. during primary inspection at B. Braun and consequently reducing visual sampling and inspection during secondary inspection at BWXT Medical Ltd