|
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 | S001 |
Date Received | 03/25/2003 |
Decision Date | 04/24/2003 |
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 ADDITIONAL WARNING ON THE LABEL. |