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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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Applicant
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PMA
Number
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Decision
Date
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concerto, right ventricular lead integrity alert, concerto-ii crt-d, consulta crt-d, insync icd, insync ii marquis, insy MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S373 06/11/2013
cardiac resynchronization therapy defibrillator (crt-d) devices MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S381 04/10/2014
brava crt-d; viva s crt-d; viva xt crt-d MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S398 10/29/2013
brava crt-d, viva s crt-d, viva xt crt-d MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S404 06/20/2014
concerto ii crt-d, consulta icd, maximo ii crt-d, protecta crt-d, protecta xt crt-d MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S420 04/11/2014
concerto ii, consulta, maximo ii, protecta, & protecta xt crt-d's MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S485 03/30/2015
concerto, insync, macimo, protecta and viva families and brava crts-d's MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S505 08/17/2015
concerto ii crt-d, consulta crt-d, maximo ii crt-d, protecta crt-d, protect xt crt-d MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S519 11/25/2015
viva, brava, protecta xt, concerto, concerto ii, consulta, maximo ii, insync ii protect MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S520 12/08/2015
brava, brava quad, concerto, concerto ii, consulta, maximo ii,protecta, protecta xt, viva quad, viva s, viva xt MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P010031S521 01/13/2016

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