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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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celerity 2d 75, celerity 2d 85,celerity 3d 75, cel... BIOTRONIK, INC. P070008 S064 01/28/2016
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
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S287 05/03/2016
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015 S288 02/22/2016
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
crt-p resynchronization devices: invive, intua, vi... GUIDANT CORP. P030005 S134 07/08/2016
ingenio™ 2 crt-p devices; valitude™ model: u125; v... GUIDANT CORP. P030005 S137 06/20/2016
invive crt-p models v172, v173; intua crt-p models... GUIDANT CORP. P030005 S147 12/12/2016
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