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).
| Device | SIR-SPHERES |
| Generic Name | Microspheres Radionuclide |
| Applicant | Sirtex Medical Pty Ltd |
| Date Received | 1999-10-25 |
| Decision Date | 2002-03-05 |
| Notice Date | 2003-01-23 |
| PMA | P990065 |
| Supplement | S |
| Product Code | NAW |
| Docket Number | 03M-0010 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sirtex Medical Pty Ltd shop 6 207 Pacific Highway st Leonards, New South Wales 2065 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990065 | | Original Filing |
| S012 |
2022-03-21 |
30-day Notice |
| S011 | | |
| S010 |
2016-12-19 |
Special (immediate Track) |
| S009 |
2016-08-08 |
Normal 180 Day Track No User Fee |
| S008 |
2015-01-15 |
30-day Notice |
| S007 |
2014-09-09 |
Special (immediate Track) |
| S006 |
2011-09-19 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 |
2006-05-15 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 | | |
| S001 |
2003-03-25 |
Special (immediate Track) |
NIH GUDID Devices