PMA P200029S007
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S007
- Product code
- NAW
- Decision date
- 2023-12-18
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- 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.
Current openFDA PMA Record#
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S007
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2023-12-18
- Decision code
- OK30
- Date received
- 2023-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.