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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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in pact admiral paclitaxel-coating percutaneous transluminal angioplasty balloon catheter MEDTRONIC Inc. P140010S002 06/19/2015
bd prepmate slide processor, bd prepmate automated accessory BD Diagnostic Systems P970018S031 06/14/2015
enlite glucose sensor MEDTRONIC Inc. P120010S058 06/09/2015
access hybritech free psa reagent assay BECKMAN COULTER, INC. P970038S030 06/09/2015
zilver ptx drug-eluting peripheral stent Cook Ireland, Ltd. P100022S013 06/08/2015
lcs total knee system DEPUY, INC. P830055S157 06/05/2015
thoratec heartmate ii lvas Abbott Medical P060040S041 06/03/2015
vns therapy aspiresr LivaNova USA, Inc. P970003S173 05/29/2015
consulta crt-p, syncra crt-p and viva crt-p MEDTRONIC Inc. P010015S270 05/27/2015
advisa dr ipg, advisa sr mri ipg and advisa dr mri ipg MEDTRONIC Inc. P980035S420 05/27/2015

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