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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 109 Results
productcode NIK PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS... BIOTRONIK, INC. P000009 S064 04/13/2016
PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENA... BIOTRONIK, INC. P000009 S065 05/02/2016
DYNAGEN™ CRT-D Models G150, G151, G154, G156, G158... Boston Scientific Corp. P010012 S406 03/28/2016
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S408 02/05/2016
Dynagen™ Models G150, G151, G154, G156, G158; Inog... Boston Scientific Corp. P010012 S410 03/09/2016
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S411 05/03/2016
DYNAGEN ™ CRT-D G150, G151, G154; DYNAGEN ™ X4 CRT... Boston Scientific Corp. P010012 S412 03/23/2016
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIR... Boston Scientific Corp. P010012 S413 04/20/2016
Dynagen, Inogen, Origen Cardiac Resynchronization ... Boston Scientific Corp. P010012 S414 04/14/2016
Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Or... Boston Scientific Corp. P010012 S415 05/09/2016
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