TheraSphere
FDA premarket approval P200029/S009 · decided 2024-04-05
Approval details
- PMA number
- P200029
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TheraSphere
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-03-14
- Decision date
- 2024-04-05
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- approval to enhance the criteria for visual sampling and inspection of the TheraSphere Administration Sets manufactured by B. Braun Medical Inc. during primary inspection at B. Braun and consequently reducing visual sampling and inspection during secondary inspection at BWXT Medical Ltd
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