|
Device | IMMUNO 1 COMPLEXED PSA ASSAY |
Generic Name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P990055 |
Supplement Number | S005 |
Date Received | 03/28/2002 |
Decision Date | 09/04/2002 |
Product Code |
NAF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE. |