|
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 |
Supplement Number | S006 |
Date Received | 09/19/2011 |
Decision Date | 07/17/2012 |
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 SINGAPORE PTE LTD. IN SINGAPORE. |