PMA P200029S012

Device: TheraSphere™
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S012
Product code: NAW
Decision date: 2026-04-10
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200029/S011.

Current openFDA PMA Record#

Device: TheraSphere™
Applicant: Boston Scientific Corporation
PMA number: P200029
Supplement: S012
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-03-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200029/S011.