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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NKE PMA Number p Decision Date From 1/1/2011 Decision Date To 1/1/2012
 
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Device
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PMA
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RENEWAL TR CRT-P DEVICES GUIDANT CORP. P030005 S080 12/05/2011
VARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEA... BIOTRONIK, INC. P070008 S027 12/02/2011
LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS BIOTRONIK, INC. P000009 S046 09/30/2011
LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR... BIOTRONIK, INC. P050023 S046 09/30/2011
COROX OTW-L BP LEADS BIOTRONIK, INC. P070008 S026 09/30/2011
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO BIOTRONIK, INC. P950037 S098 09/30/2011
FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS Abbott Medical P030035 S087 09/08/2011
EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS Abbott Medical P030054 S198 09/08/2011
SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS St. Jude Medical, Inc. P880006 S073 09/08/2011
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF... Abbott Medical P880086 S208 09/08/2011
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