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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.
 
DeviceTOP2A FISH PHARMDX
Generic NameFluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
ApplicantDAKO DENMARK A/S
42 PRODUKTIONSVEJ
2600 GLOSTRUP DK-26-2600
PMA NumberP050045
Supplement NumberS002
Date Received03/06/2008
Decision Date03/26/2008
Withdrawal Date 01/24/2018
Product Code NXG 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.
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