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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namereader, cervical cytology slide, automated
Generic Namesemi-automated cervical "pap" smear rescreening
PMA NumberP940029
Date Received09/21/1994
Decision Date11/08/1995
Withdrawal Date 06/04/2009
Product Code
MNM[ Registered Establishments with MNM ]
Docket Number 96M-0472
Notice Date 12/11/1996
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the papnet testing system.
Supplements: S001 S002 S003