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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 IMAGING SYSTEM LABELING
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP020002
Supplement NumberS005
Date Received08/19/2010
Decision Date09/16/2010
APCB Date 03/22/2017
Product Code MNM 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
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