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 | S011 |
Date Received | 03/18/2015 |
Decision Date | 04/22/2015 |
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 CHANGE TO REMOVE EXTRANEOUS IN-PROCESS STABILITY TESTS PERFORMED ON THE STRIPS (STR) AND ON THE SOLID PHASE RECEPTACLES (SPR) OF THE KIT, AND CONSEQUENTLY TO ADD AN INSTRUCTION FOR THE STORAGE OF THE STR DURING THE MANUFACTURING PROCESS. |
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