|
Device | SIR-SPHERE 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 | S007 |
Date Received | 09/09/2014 |
Decision Date | 10/09/2014 |
Product Code |
NAW |
Advisory Committee |
Radiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W). |