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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Decision
Date
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enlite sensor MEDTRONIC Inc. P120010S030 02/04/2015
therakos uvar xts photopheresis system Mallinckrodt Pharmaceuticals Ireland Limited P860003S077 02/03/2015
thxid-braf kit bioMerieux, Inc. P120014S001 01/30/2015
sof-sensor MEDTRONIC MINIMED P980022S167 01/29/2015
enlite sensor MEDTRONIC Inc. P120010S042 01/29/2015
guardian real time monitor MEDTRONIC MINIMED P980022S168 01/28/2015
enlite glucose sensors MEDTRONIC Inc. P120010S041 01/28/2015
ams 800 artificial urinary sphincter Boston Scientific Corp. P000053S053 01/28/2015
infuse(r) bone graft/lt-cage lumbar tapered fusion device Medtronic Sofamor Danek USA, Inc. P000058S058 01/27/2015
endurant and endurant ii stent system, endurant ii aorto-uni-lliac(aui) stent graft system, endurant iis stent graft sys Medtronic Vascular P100021S041 01/22/2015

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