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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
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP080015
Supplement NumberS003
Date Received01/18/2011
Decision Date02/03/2011
Withdrawal Date04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SEVERAL CHANGES TO THE CERVISTA HPV 16/18 SOFTWARE AND LABELING. CHANGES INCLUDE THE COMPANY NAME CHANGE FROM THIRD WAVE TO HOLOGIC, NUMEROUS USER INTERFACE CHANGES, AND SEPARATING THE INVADER CALL REPORTER AND CERVISTA HPV 16/18 SOFTWARE ON TO SEPARATE CDS WITH NEW PART NUMBERS.
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