|
Device | DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S025 |
Date Received | 05/03/2013 |
Decision Date | 05/28/2013 |
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 CHANGE THE SUPPLIER FOR DEXTRAN T110 FROM SIGMA ADRICH FINE CHEMICALS(SAFC) TO PHARMACOMOS AND TO BRING PHTHALOCYANINE MANUFACTURE IN-HOUSE AT THE SIEMENSHEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE SITE AND THE SCALE-UP OF THE SENSIBEAD CONCENTRATE PRODUCTION FROM 150G PER LOT SIZE TO 300G. |