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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 35 Results
productcode NKE PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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valitude crt-p, accolade crt-p GUIDANT CORP. P030005 S140 08/10/2016
valitude crt-p GUIDANT CORP. P030005 S139 08/02/2016
anthem, allure/rf, allure quadra/rf family of crt-... Abbott Medical P030035 S147 07/25/2016
crt-p resynchronization devices: invive, intua, vi... GUIDANT CORP. P030005 S134 07/08/2016
anthem and frontier ii crt-p's Abbott Medical P030035 S146 06/28/2016
stratos lv/lv-t, evia/entovis hf/hf-t, eluna/erins... BIOTRONIK, INC. P070008 S073 06/24/2016
ingenio™ 2 crt-p devices; valitude™ model: u125; v... GUIDANT CORP. P030005 S137 06/20/2016
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S072 05/27/2016
valitude, valitude x4, invive, intua GUIDANT CORP. P030005 S135 05/25/2016
cardiac resynchronization therapy- pacemaker (crt-... GUIDANT CORP. P030005 S136 05/25/2016