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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREVIEW SCOPE MANUAL
Classification Namereader, cervical cytology slide, automated
Generic Nameautomated microscope for cytology
ApplicantHOLOGIC, INC.
PMA NumberP020002
Supplement NumberS006
Date Received11/29/2011
Decision Date01/23/2012
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Hematology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the review scope manual+.
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