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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
Devicecobas HPV Test, 240 Tests
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS025
Date Received07/28/2017
Decision Date07/02/2018
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for an expansion of the intended use for the FDA-approved cobas HPV Test to include cervical specimens collected in SurePath Preservative Fluid as a specimen type
Post-Approval StudyShow Report Schedule and Study Progress
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