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 | VIDAS TOTAL PSA |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
PMA Number | P040008 |
Supplement Number | S005 |
Date Received | 02/06/2013 |
Decision Date | 03/08/2013 |
Withdrawal Date
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10/11/2017 |
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 ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY. |
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