PMA P200029S002
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S002
- Product code
- NAW
- Decision date
- 2021-08-19
- Generic name
- Microspheres radionuclide
- Approval order statement
- Approval for removing the needleless luer component from the TheraSphere Administration Sets.
Current openFDA PMA Record#
- Device
- TheraSphere
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S002
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2021-08-19
- Decision code
- APPR
- Date received
- 2021-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for removing the needleless luer component from the TheraSphere Administration Sets.