PMA P990065S015
- Device
- SIR-Spheres Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S015
- Product code
- NAW
- Decision date
- 2024-03-06
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- Approval order statement
- a process change to allow for an additional volume size (SIR-Y002, 1.8 GBq/3 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
- S015
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2024-03-06
- Decision code
- OK30
- Date received
- 2024-02-09
- 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-Y002, 1.8 GBq/3 mL) to the existing SIR-Spheres® Y-90 resin microspheres product line