|
Device | IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA |
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 | S021 |
Date Received | 06/19/2019 |
Decision Date | 07/11/2019 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the product quality control (QC) method in order to enhance the safety of IMMULITE® Third Generation PSA High Adjustor (LUPH), IMMULITE® Systems PSA High Adjustor (LPSH) and IMMULITE® 2000 Systems PSA High Adjustor (LPSH) |