PMA P990065S012
- Device
- SIR-Spheres Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S012
- Product code
- NAW
- Decision date
- 2022-04-12
- Generic name
- Microspheres radionuclide
- Approval order statement
- Addition of an alternate qualified supplier (Niowave, Inc.) for a critical raw material, Y-90 chloride solution.
Current openFDA PMA Record#
- Device
- SIR-Spheres Y-90 resin microspheres
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P990065
- Supplement
- S012
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2022-04-12
- Decision code
- OK30
- Date received
- 2022-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate qualified supplier (Niowave, Inc.) for a critical raw material, Y-90 chloride solution.