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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 35 Results
productcode NKE PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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PMA
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CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P MEDTRONIC Inc. P010015 S287 05/03/2016
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL... GUIDANT CORP. P030005 S133 05/03/2016
PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENA... BIOTRONIK, INC. P000009 S065 05/02/2016
COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP... BIOTRONIK, INC. P070008 S070 05/02/2016
BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS... BIOTRONIK, INC. P000009 S064 04/13/2016
STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T BIOTRONIK, INC. P070008 S069 04/13/2016
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW... BIOTRONIK, INC. P070008 S071 03/29/2016
CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P MEDTRONIC Inc. P010015 S291 03/01/2016
Consulta CRT-P C4TR01; Syncra CRT-P C2TR01 MEDTRONIC Inc. P010015 S292 02/29/2016
CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P MEDTRONIC Inc. P010015 S288 02/22/2016
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