|
Device | SIR-SPHERES |
Generic Name | Microspheres radionuclide |
Applicant | Sirtex Medical Pty Ltd Shop 6 207 Pacific Highway St Leonards, New South Wales 2065 |
PMA Number | P990065 |
Date Received | 10/25/1999 |
Decision Date | 03/05/2002 |
Product Code |
NAW |
Docket Number | 03M-0010 |
Notice Date | 01/23/2003 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR SIR-SPHERES. THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL CANCER WITH ADJUVANT INTRA-HEPATIC ARTERY CHEMOTHERAPY (IHAC) OF FUDR (FLOXURIDINE). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S004 S006 S007 S008 S009 S010 S012 S013 S015 |