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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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consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S287 05/03/2016
contak renewal models h125 and h120 with the model... GUIDANT CORP. P030005 S133 05/03/2016
corox otw 75 bp & 85 bp; corox otw-l 75 bp & 85 bp... BIOTRONIK, INC. P070008 S070 05/02/2016
programmer software (1507.u) for the ics 3000/rena... BIOTRONIK, INC. P000009 S065 05/02/2016
belos dr/dr-t/vr-vr-t lexos dr/dr-t/vr-vr-t; lumos... BIOTRONIK, INC. P000009 S064 04/13/2016
stratos lv/lv-t, evia hf/hf-t; entovis hf/hf-t BIOTRONIK, INC. P070008 S069 04/13/2016
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S071 03/29/2016
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S291 03/01/2016
consulta crt-p c4tr01; syncra crt-p c2tr01 MEDTRONIC Inc. P010015 S292 02/29/2016
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S288 02/22/2016
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