TheraSphere
FDA premarket approval P200029/S002 · decided 2021-08-19
Approval details
- PMA number
- P200029
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-07-22
- Decision date
- 2021-08-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for removing the needleless luer component from the TheraSphere Administration Sets.
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