|
Device | PSA IMMULITE ASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. GLYN RHONWY, LLANBERIS GWYNEDD LL55 4EL LL554 |
PMA Number | P930027 |
Supplement Number | S012 |
Date Received | 08/08/2011 |
Decision Date | 09/07/2011 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE. THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE. FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY. |