PMA P200029S013

Device: TheraSphere™ Y-90 Glass Microspheres System
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S013
Product code: NAW
Decision date: 2026-06-04
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: Approval of the ongoing quality assurance approach to ensure continued alignment with historical National Institute of Standards and Technology (NIST) traceability for TheraSphere Yttrium-90 Glass Microspheres at BWXT Medical Limited

Current openFDA PMA Record#

Device: TheraSphere™ Y-90 Glass Microspheres System
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S013
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2026-06-04
Decision code: OK30
Date received: 2026-05-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the ongoing quality assurance approach to ensure continued alignment with historical National Institute of Standards and Technology (NIST) traceability for TheraSphere Yttrium-90 Glass Microspheres at BWXT Medical Limited