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Sir-Spheres

by Sirtex Medical, Inc. FDA registration: United States PMA

PMA P990065 Product code NAW

Overview

Sir-Spheres is a microspheres radionuclide device indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine). It is manufactured by Sirtex Medical, Inc. and received FDA PMA approval under P990065.

The device is supplied as a sterile, single-use product intended for intra-arterial delivery in a hospital setting. It is regulated as a Class III medical device and is not MRI safe due to its radioactive composition. Storage and handling must follow radiation safety protocols.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP990065 Date5 Mar 2002ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

1 recall · FDA

    • Terminated Z-1162-2013 FDA Class III initiated 27 Feb 2013

    Incorrect expiration date

Specification

PMA · synced 6 Oct 2026

Generic Name
Microspheres radionuclide
PMA Number
FDA Product Code
NAW
Device Class
Class III
Advisory Committee
Radiology
FDA Decision
APPR Approved

Other devices from Sirtex Medical, Inc.

See all devices from Sirtex Medical, Inc. →

Questions

  • What is Sir-Spheres used for?

    Sir-Spheres is indicated for the treatment of unresectable metastatic liver tumors originating from primary colorectal cancer when used with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine), as stated in the device's approval documentation.

  • Is Sir-Spheres a single-use or reusable device?

    Sir-Spheres is supplied as a sterile, single-use device intended for one-time administration via intra-arterial delivery, based on its classification as a radionuclide microsphere product requiring aseptic handling and radiation safety controls.

  • What regulatory authorization does Sir-Spheres have?

    Sir-Spheres received FDA Premarket Approval (PMA) under application number P990065, with approval granted on March 5, 2002, for the specified indication in colorectal cancer liver metastases.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P990065 24 fields · synced 6 Oct 2026