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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.
 
DeviceTHINPREP-5000
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
Applicant
HOLOGIC, INC.
250 campus drive
marlborough, MA 01752
PMA NumberP950039
Supplement NumberS026
Date Received06/27/2013
Decision Date03/02/2015
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THINPREP 5000 PROCESSOR.
Post-Approval StudyShow Report Schedule and Study Progress
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