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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 29 Results
productcode NKE PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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allure, allure quadra, quadra allure mp Abbott Medical P030035 S163 01/03/2018
contak renewal models h125 and h120 with the model... GUIDANT CORP. P030005 S165 01/07/2018
allure, allure quadra, quadra allure mp, anthem, a... Abbott Medical P030035 S165 02/01/2018
ingenio crt-p devices (invive, intua), ingenio 2 c... GUIDANT CORP. P030005 S171 02/02/2018
valitude crt-p; valitude x4 crt-p; visionist GUIDANT CORP. P030005 S173 02/08/2018
stratos lv crt-p / stratos lv-t crt-p / corox otw ... BIOTRONIK, INC. P070008 S088 02/15/2018
corox otw bp/otw-s bp; corox otw-l bp/promri otw-l... BIOTRONIK, INC. P070008 S089 02/21/2018
anthem, allure, allure rf, allure quadra, allure q... Abbott Medical P030035 S166 02/22/2018
assure crt-p Abbott Medical P030035 S167 03/05/2018
accolade cardiac resynchronization therapy-pacemak... GUIDANT CORP. P030005 S174 03/12/2018