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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; COBAS HPV TEST 960 TESTS
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS012
Date Received11/05/2013
Decision Date12/16/2013
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE SOFTWARE OF THE COBAS Z480 AMPLIFICATION/ DETECTION ANALYZER, WHICH IS A COMPONENT OF THE COBAS 4800 SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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