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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.
 
DeviceBD FOCALPOINT GS IMAGING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBd Diagnostics
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP950009
Supplement NumberS021
Date Received05/19/2016
Decision Date06/17/2016
Product Code MNM 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.
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