|
Device | ADVIA CENTAUR PSA & CPSA ASSAYS |
Generic Name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P990055 |
Supplement Number | S011 |
Date Received | 02/06/2009 |
Decision Date | 03/06/2009 |
Product Code |
NAF |
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 CHANGE INVOLVING THE CONJUGATED ANTIBODIES FOR THE DEVICE. |