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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 29 Results
productcode NKE PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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invive crt-p, intua crt-p, valitude crt-p, visioni... GUIDANT CORP. P030005 S176 07/27/2018
evia hf, hf-t, entovis hf, hf-t, edora 8 hf-t, eni... BIOTRONIK, INC. P070008 S091 06/19/2018
allure, allure quadra, quadra allure mp, and anthe... Abbott Medical P030035 S170 06/15/2018
evia hf /hf-t; entovis hf/ hf-t ; edora 8 hf-t; en... BIOTRONIK, INC. P070008 S093 06/13/2018
allure, allure quadra, quadra allure mp Abbott Medical P030035 S169 05/03/2018
contak renewal models h125 and h120 with the model... GUIDANT CORP. P030005 S175 04/25/2018
allure rf, allure quadra rf, allure quadra, allure... Abbott Medical P030035 S168 04/25/2018
anthem, allure/rf, allure quadra/rf family of crt-... Abbott Medical P030035 S164 04/11/2018
invive, intua, visionist, valitude GUIDANT CORP. P030005 S172 03/26/2018
accolade cardiac resynchronization therapy-pacemak... GUIDANT CORP. P030005 S174 03/12/2018