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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
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concerto/concerto ii; consulta; maximo ii; and protecta/protecta xt MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S232 04/04/2012
carelink home monitor model 2491 Medtronic, Inc. P890003S245 03/22/2012
advia centaur anti-hbs2 (ahbs2) assay and qaulity control material SIEMENS HEALTHCARE DIAGNOSTICS INC. P100039 01/20/2012
elca coronary atherectomy catheters SPECTRANETICS CORP. P910001S047 01/13/2012
thermocool sf nav bi-directional catheter (d-1313-xx-s, d-1317-xx-s) and thermocool sf bi-directional catheter BIOSENSE WEBSTER, INC. P030031S025 12/21/2011
dimension vista fpsa flex reagent cartridge for use on the dimension vista 500 system SIEMENS HEALTHCARE DIAGNOSTICS P020027S015 11/23/2011
lifestent solo vascular stent system BARD PERIPHERAL VASCULAR, INC. P070014S026 10/26/2011
suture medicated closure systems, percutaneous vascular surgical systems and associated accesories ABBOTT VASCULAR INC. P960043S074 08/10/2011
solesta injectable gel Palette Life Sciences P100014 05/27/2011
afx endovascular aaa system Endologix, LLC P040002S031 05/06/2011

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