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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 NumberS004
Date Received11/13/2020
Decision Date12/10/2020
Product Code MAQ 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implement an automated QC test for a kit component.
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