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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT productcode NVZ Decision Date To 03/28/2024
 
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PMA
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EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S569 04/15/2016
CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S499 05/04/2015
CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S451 09/05/2014
BRAVA,CONCERTO II, MAXIMO II PRTECTA CRT-D,CONCERT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S438 05/23/2014
INSYNC II PROTECT ICD, INSYNC III MARQUIS ICD,INSY... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S416 02/27/2014
INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S397 02/14/2014
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSY... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S377 07/23/2013
CONCERT II, CONSULTA, & MAXIMO II CRT-DS MEDTRONIC CARDIAC RHYTHM DISEA P010031 S296 06/04/2012
CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO CRT-D ICDS MEDTRONIC CARDIAC RHYTHM DISEA P010031 S150 04/04/2011
PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE C... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S171 03/25/2011
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