SIR-Spheres Y-90 resin microspheres
FDA premarket approval P990065/S013 · decided 2023-08-09
Approval details
- PMA number
- P990065
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIR-Spheres Y-90 resin microspheres
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2023-07-10
- Decision date
- 2023-08-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Manufacturing change to add the Y-90 chloride solution manufacturing facility in Wilmington, Massachusetts USA for the current supplier Eckert & Ziegler Radiopharma (EZR or E&Z).
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