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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 NumberS003
Date Received09/17/2020
Decision Date10/07/2020
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes being effected to update hazard labeling.
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