SIR-SPHERES
FDA premarket approval P990065/S017 · decided 2025-04-11
Approval details
- PMA number
- P990065
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-SPHERES
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2025-03-14
- Decision date
- 2025-04-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- a change in manufacturing to update the number of vendor vials from one Y-90 vendor vial to two Y-90 vendor vials that can be used to manufacture SIR-Spheres bulk batch volumes of 42 mL to 52 mL
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