PMA P990065S017

Device: SIR-SPHERES
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S017
Product code: NAW
Decision date: 2025-04-11
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: a change in manufacturing to update the number of vendor vials from one Y-90 vendor vial to two Y-90 vendor vials that can be used to manufacture SIR-Spheres bulk batch volumes of 42 mL to 52 mL

Current openFDA PMA Record#

Device: SIR-SPHERES
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S017
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2025-04-11
Decision code: OK30
Date received: 2025-03-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in manufacturing to update the number of vendor vials from one Y-90 vendor vial to two Y-90 vendor vials that can be used to manufacture SIR-Spheres bulk batch volumes of 42 mL to 52 mL