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U.S. Department of Health and Human Services

Premarket Approval - PMA

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Device Name
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PMA
Number
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Decision
Date
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consulta crt-p, syncra crt-p and viva crt-p MEDTRONIC Inc. P010015S270 05/27/2015
consulta crt-p, insync, insync iii, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015S275 08/17/2015
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015S285 12/08/2015
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015S286 11/25/2015
consulta crt-p, syncra crt-p, viva crt-p MEDTRONIC Inc. P010015S288 02/22/2016
lifevest wearable defibrillator ZOLL MANUFACTURING CORPORATION P010030S041 04/16/2013
lifevest wearable defibrillator ZOLL MANUFACTURING CORPORATION P010030S042 07/22/2013
concerto/concerto ii; consulta; maximo ii; and protecta/protecta xt MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S232 04/04/2012
concert ii/consulta/insync ii/iii marquis/maximo/sentry/maximo ii protecta/xt/insync marquis/insync ii protect/concerto MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S280 12/06/2011
viva xt crt-d, viva s crt-d, brava crt-d, viva/brava/evera software application MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S318 01/29/2013

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