PMA P990065S019
- Device
- SIR-Spheres® Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S019
- Product code
- NAW
- Decision date
- 2026-05-07
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- Approval order statement
- a process change to allow for an additional volume size (SIR-Y003, 0.6 GBq/1 mL) to the existing SIR-Spheres® Y-90 resin microspheres product line
Current openFDA PMA Record#
- Device
- SIR-Spheres® Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S019
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2026-05-07
- Decision code
- OK30
- Date received
- 2026-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a process change to allow for an additional volume size (SIR-Y003, 0.6 GBq/1 mL) to the existing SIR-Spheres® Y-90 resin microspheres product line