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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.
 
DevicePAPNET (R) TESTING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBD DIAGNOSTICS
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP940029
Supplement NumberS001
Date Received01/31/1996
Decision Date10/21/1996
Withdrawal Date 06/04/2009
Product Code MNM 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SECOND INDICATION FOR USE
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