Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY. LLANBERIS CAERNARFON GWYNEDD, LL55 4EL |
PMA Number | P060005 |
Supplement Number | S011 |
Date Received | 07/23/2020 |
Decision Date | 08/18/2020 |
Product Code |
MTG |
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 Removal of redundant annual stability testing. |
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