TheraSphereTM Y-90 Glass Microspheres System
FDA premarket approval P200029/S008 · decided 2024-02-07
Approval details
- PMA number
- P200029
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TheraSphereTM Y-90 Glass Microspheres System
- Generic name
- Microspheres radionuclide
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-01-19
- Decision date
- 2024-02-07
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- approval to implement ISO 80369 compliant luers in the TheraSphere Administration Sets manufactured by CEA Medical Manufacturing (CEA)
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510(k) clearances by this applicant
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