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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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productcode OYB PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
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Device
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Applicant
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PMA
Number
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Decision
Date
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APTIMA HPV ASSAY GEN-PROBE INCORPORATED P100042 S003 07/07/2014
APTIMA HPV ASSAY GEN-PROBE INCORPORATED P100042 S002 04/29/2014
APTIMA HPV 16 18/45 GENETYPE ASSAY GEN-PROBE INCORPORATED P120007 S002 04/29/2014
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