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. |
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Device | TOP2A FISH PHARMDX |
Generic Name | Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion |
Applicant | DAKO DENMARK A/S 42 PRODUKTIONSVEJ 2600 GLOSTRUP DK-26-2600 |
PMA Number | P050045 |
Supplement Number | S002 |
Date Received | 03/06/2008 |
Decision Date | 03/26/2008 |
Withdrawal Date
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01/24/2018 |
Product Code |
NXG |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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