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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 35 Results
productcode NKE PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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ANTHEM AND FRONTIER II CRT-P'S Abbott Medical P030035 S146 06/28/2016
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-... Abbott Medical P030035 S147 07/25/2016
Allure, Allure RF, Allure Quadra, Allure Quadra RF... Abbott Medical P030035 S148 08/19/2016
Allure, Allure Quadra, Quadra Allure MP Abbott Medical P030035 S149 09/27/2016
ALLURE QUADRA, RF, MP Abbott Medical P030035 S150 11/17/2016
BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS... BIOTRONIK, INC. P000009 S064 04/13/2016
PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENA... BIOTRONIK, INC. P000009 S065 05/02/2016
CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CEL... BIOTRONIK, INC. P070008 S064 01/28/2016
STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T BIOTRONIK, INC. P070008 S069 04/13/2016
COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP... BIOTRONIK, INC. P070008 S070 05/02/2016
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