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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
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588
PMA NumberP190028
Supplement NumberS009
Date Received05/08/2023
Decision Date05/14/2024
Product Code MAQ 
Docket Number 24M-2536
Notice Date 05/31/2024
Advisory Committee Microbiology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for using self-collected vaginal specimens, obtained in a healthcare setting, which can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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