Approval for changes in device package insert with insertion of bsa model to replace the current empirical model for calculation of individual required activity dose, change of lung shunt fraction to total lung dose, less than 30 gy to apply in the dose calculation, re-define the radio-embolization induced liver disease (reild) and addition of dose reduction guidance in reild, addition of guidance of lobar therapy using bsa model, and deletion of empirical model and partition model for dose calculation.
| Device | SIR-SPHERES MICROSPHERES |
| Generic Name | Microspheres Radionuclide |
| Applicant | Sirtex Medical Pty Ltd |
| Date Received | 2016-12-19 |
| Decision Date | 2017-01-18 |
| PMA | P990065 |
| Supplement | S010 |
| Product Code | NAW |
| Advisory Committee | Radiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sirtex Medical Pty Ltd shop 6 207 Pacific Highway st Leonards, New South Wales 2065 |
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