PMA P200029S006

Device: TheraSphere
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S006
Product code: NAW
Decision date: 2024-02-06
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: Approval for modifications to the labeling which included updates to address new quality system requirements, MR safe labeling, and clarifications in the user manuals.

Current openFDA PMA Record#

Device: TheraSphere
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S006
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2024-02-06
Decision code: APPR
Date received: 2023-11-08
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the labeling which included updates to address new quality system requirements, MR safe labeling, and clarifications in the user manuals.