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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 35 Results
productcode NKE PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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attain bipolar otw lead, attain otw lv lead MEDTRONIC Inc. P010015 S289 01/13/2016
attain bipolar otw lead, attain otw lv lead, consu... MEDTRONIC Inc. P010015 S290 01/25/2016
celerity 2d 75, celerity 2d 85,celerity 3d 75, cel... BIOTRONIK, INC. P070008 S064 01/28/2016
valitude , valitude x4 crt-ps GUIDANT CORP. P030005 S132 02/03/2016
invive, intua, visionist, valitude crt-p resynchro... GUIDANT CORP. P030005 S131 02/05/2016
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S288 02/22/2016
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 S291 03/01/2016
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S071 03/29/2016
belos dr/dr-t/vr-vr-t lexos dr/dr-t/vr-vr-t; lumos... BIOTRONIK, INC. P000009 S064 04/13/2016
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