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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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pulse generator, pacemaker, implatable, with cardi... BIOTRONIK, INC. P070008 S090 12/19/2018
allure, allure quadra and quadra allure mp Abbott Medical P030035 S176 12/11/2018
invive, intua, valitude, valitude x4, visionist, v... GUIDANT CORP. P030005 S178 11/16/2018
allure, allure quadra, quadra allure mp Abbott Medical P030035 S174 10/24/2018
stratos, evia, entoivs, eluna 8, epyra 8, and etri... BIOTRONIK, INC. P070008 S097 10/22/2018
allura, allure quadra/ quadra allure mp Abbott Medical P030035 S173 10/01/2018
siello t 53; siello t 60; siello jt 45; siello jt ... BIOTRONIK, INC. P070008 S096 08/27/2018
psw 1801.u BIOTRONIK, INC. P070008 S092 08/15/2018
anthem; allure, allure quadra; quadra allure mp Abbott Medical P030035 S172 08/14/2018
corox otw bp; corox otw-l bp; corox promri otw bp;... BIOTRONIK, INC. P070008 S095 08/09/2018
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