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TheraSphere Microspheres Radionuclide

by Boston Scientific

PMA P200029

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P200029↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200029 Date17 Mar 2021ApprovedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2327-2021 FDA Class II initiated 23 Jul 2021
    • Ongoing Z-2328-2021 FDA Class II initiated 23 Jul 2021

    Potential for leaks and loosening at the patient catheter connection

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
TheraSphere
Generic name
Microspheres radionuclide
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
NAW
Device class
Class III
Advisory committee
Radiology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

TheraSphere is a selective internal radiation therapy (SIRT) device classified as Microspheres Radionuclide, designed for localized tumor control. It consists of radioactive microspheres delivered directly to the liver via the hepatic artery to treat unresectable hepatocellular carcinoma (HCC) in carefully selected patients.

The device is supplied as a sterile, single-use system and requires administration by trained medical professionals in a radiology setting. Approved under FDA PMA (P200029), it is intended for use in patients with solitary HCC tumors (1–8 cm) meeting specific clinical criteria, including Child-Pugh Score A cirrhosis and no macrovascular invasion. Storage and handling must comply with radiation safety protocols.

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