PMA P990065S016
- Device
- SIR-Spheres Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S016
- Product code
- NAW
- Decision date
- 2025-01-02
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- Approval order statement
- for a change in manufacturing to expand the SIR-Spheres batch size range
Current openFDA PMA Record#
- Device
- SIR-Spheres Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S016
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2025-01-02
- Decision code
- OK30
- Date received
- 2024-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a change in manufacturing to expand the SIR-Spheres batch size range