SIR-Spheres Y-90 resin microspheres
FDA premarket approval P990065/S012 · decided 2022-04-12
Approval details
- PMA number
- P990065
- Supplement
- S012
- 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
- 2022-03-21
- Decision date
- 2022-04-12
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Addition of an alternate qualified supplier (Niowave, Inc.) for a critical raw material, Y-90 chloride solution.
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