PMA P990065S014

Device: SIR-Spheres Y-90 resin microspheres
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S014
Product code: NAW
Decision date: 2025-07-01
Classification: Radiology
Generic name: Microspheres radionuclide
Approval order statement: SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child Pugh-A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

Current openFDA PMA Record#

Device: SIR-Spheres Y-90 resin microspheres
Applicant: Sirtex Medical, Inc.
PMA number: P990065
Supplement: S014
Product code: NAW
Generic name: Microspheres radionuclide
Decision date: 2025-07-01
Decision code: APPR
Date received: 2024-01-16
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child Pugh-A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).