TheraSphere
FDA premarket approval P200029/S010 · decided 2024-09-24
Approval details
- PMA number
- P200029
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-05-28
- Decision date
- 2024-09-24
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- for labeling update with the results obtained from the post-approval study
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