PMA P200029S005
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S005
- Product code
- NAW
- Decision date
- 2023-07-26
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- 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.
Current openFDA PMA Record#
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S005
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2023-07-26
- Decision code
- OK30
- Date received
- 2023-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.