PMA P990065S013

Device: SIR-Spheres Y-90 resin microspheres
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S013
Product code: NAW
Decision date: 2023-08-09
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: Manufacturing change to add the Y-90 chloride solution manufacturing facility in Wilmington, Massachusetts USA for the current supplier Eckert & Ziegler Radiopharma (EZR or E&Z).

Current openFDA PMA Record#

Device: SIR-Spheres Y-90 resin microspheres
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S013
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2023-08-09
Decision code: OK30
Date received: 2023-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to add the Y-90 chloride solution manufacturing facility in Wilmington, Massachusetts USA for the current supplier Eckert & Ziegler Radiopharma (EZR or E&Z).