This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | SIR-Spheres Y-90 resin microspheres |
| Generic Name | Microspheres Radionuclide |
| Applicant | Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-04-12 |
| PMA | P990065 |
| Supplement | S012 |
| Product Code | NAW |
| Advisory Committee | Radiology |
| Supplement Type | 30-day Notice |
| 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 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Addition Of An Alternate Qualified Supplier (Niowave, Inc.) For A Critical Raw Material, Y-90 Chloride Solution. |
| 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) |
| Device ID | PMA | Supp |
|---|---|---|
| M425SIRY0010 | P990065 | 006 |
| 00850014612146 | P990065 | 015 |