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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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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VALITUDE CRT-P, ACCOLADE CRT-P GUIDANT CORP. P030005 S140 08/10/2016
VALITUDE CRT-P GUIDANT CORP. P030005 S139 08/02/2016
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-... Abbott Medical P030035 S147 07/25/2016
CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VI... GUIDANT CORP. P030005 S134 07/08/2016
ANTHEM AND FRONTIER II CRT-P'S Abbott Medical P030035 S146 06/28/2016
Stratos LV/LV-T, Evia/Entovis HF/HF-T, Eluna/Erins... BIOTRONIK, INC. P070008 S073 06/24/2016
Ingenio™ 2 CRT-P Devices; VALITUDE™ Model: U125; V... GUIDANT CORP. P030005 S137 06/20/2016
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW... BIOTRONIK, INC. P070008 S072 05/27/2016
VALITUDE, VALITUDE X4, INVIVE, INTUA GUIDANT CORP. P030005 S135 05/25/2016
CARDIAC RESYNCHRONIZATION THERAPY- PACEMAKER (CRT-... GUIDANT CORP. P030005 S136 05/25/2016
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