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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 109 Results
productcode NIK PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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Device
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PMA
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FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS Abbott Medical P030035 S138 02/12/2016
ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-... Abbott Medical P030035 S139 05/12/2016
ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE Q... Abbott Medical P030035 S141 04/28/2016
ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES Abbott Medical P030035 S144 01/04/2016
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS Abbott Medical P030054 S291 02/12/2016
PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,... Abbott Medical P030054 S292 05/12/2016
PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADR... Abbott Medical P030054 S295 04/28/2016
PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUAD... Abbott Medical P030054 S297 02/08/2016
QUICKFLEX U AND QUARTET CRT LEADS Abbott Medical P030054 S298 02/17/2016
QuickFlex u Model 1258T Abbott Medical P030054 S299 02/17/2016
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