Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TheraSphere
• Generic Name: Microspheres radionuclide
• Applicant: Boston Scientific Corporation; 300 Boston Scientific Way; Marborough, MA 01752
• PMA Number: P200029
• Supplement Number: S010
• Date Received: 05/28/2024
• Decision Date: 09/24/2024
• Product Code: NAW
• Advisory Committee: Radiology
• Clinical Trials: NCT05233098
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for labeling update with the results obtained from the post-approval study