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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 16/18
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP080015
Supplement NumberS001
Date Received06/03/2010
Decision Date06/28/2010
Withdrawal Date04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA), A RAW MATERIAL USED IN THE PRODUCTION OF ONE COMPONENT OF THE DEVICE.
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