PMA P200029S015

Device: TheraSphere™ Y-90 Glass Microspheres System
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S015
Product code: NAW
Decision date: 2026-10-13
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: approval for the reinstatement of previously approved manufacturing Room 1531 at BWXT Medical Limited for routine manufacture of TheraSphere™ Yttrium-90 Glass Microspheres.

Current openFDA PMA Record#

Device: TheraSphere™ Y-90 Glass Microspheres System
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S015
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2026-10-13
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the reinstatement of previously approved manufacturing Room 1531 at BWXT Medical Limited for routine manufacture of TheraSphere™ Yttrium-90 Glass Microspheres.