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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