|
Device | SIR-Spheres microspheres |
Generic Name | Microspheres radionuclide |
Applicant | Sirtex Medical Pty Ltd Shop 6 207 Pacific Highway St Leonards, New South Wales 2065 |
PMA Number | P990065 |
Supplement Number | S009 |
Date Received | 08/08/2016 |
Decision Date | 03/24/2017 |
Product Code |
NAW |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Sirtex Germany Manufacturing GMBH, Industriepark Hoechst, Building G808 65926 Frankfurt am Main Germany. |