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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 92 Results
productcode NVZ PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
 
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BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMO... BIOTRONIK, INC. P000009 S060 03/19/2015
BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELO... BIOTRONIK, INC. P000009 S061 04/09/2015
PHYLAX AV ICD SYSTEM BIOTRONIK, INC. P000009 S062 06/19/2015
PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC P... BIOTRONIK, INC. P000009 S063 12/21/2015
CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S499 05/04/2015
AFFINITY /INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY O... Abbott Medical P880086 S253 02/25/2015
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PA... Abbott Medical P880086 S254 04/08/2015
AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY... Abbott Medical P880086 S255 08/27/2015
ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAK... Abbott Medical P880086 S256 05/14/2015
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF... Abbott Medical P880086 S257 07/13/2015
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