TheraSphere
FDA premarket approval P200029/S006 · decided 2024-02-06
Approval details
- PMA number
- P200029
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-11-08
- Decision date
- 2024-02-06
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for modifications to the labeling which included updates to address new quality system requirements, MR safe labeling, and clarifications in the user manuals.
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