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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.
 
DeviceCervista HPV HR Assay
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01750
PMA NumberP080014
Supplement NumberS021
Date Received07/18/2018
Decision Date08/16/2018
Withdrawal Date 04/19/2023
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  
Qualification of a new supplier and purchased raw material and updates to downstream manufacturing processes.
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