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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 of 35 Results
productcode NKE PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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invive, intua, ingenio 2, valitude, valitude x4 cr... GUIDANT CORP. P030005 S143 10/12/2016
invive, intua, visionist, valitude crt-p resynchro... GUIDANT CORP. P030005 S131 02/05/2016
programmer software (1507.u) for the ics 3000/rena... BIOTRONIK, INC. P000009 S065 05/02/2016
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S072 05/27/2016
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S071 03/29/2016
stratos lv/lv-t, evia hf/hf-t; entovis hf/hf-t BIOTRONIK, INC. P070008 S069 04/13/2016
stratos lv/lv-t, evia/entovis hf/hf-t, eluna/erins... BIOTRONIK, INC. P070008 S073 06/24/2016
valitude , valitude x4 crt-ps GUIDANT CORP. P030005 S132 02/03/2016
valitude crt-p GUIDANT CORP. P030005 S144 11/03/2016
valitude crt-p GUIDANT CORP. P030005 S139 08/02/2016
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