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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 30 Results
productcode NKE PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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edora 8 crt-p, evity 8 crt-p, and enitra 8 crt-p a... BIOTRONIK, INC. P070008 S118 12/18/2020
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S121 12/18/2020
anthem, allure, allure quadra, quadra allure mp, q... Abbott Medical P030035 S183 12/15/2020
valitude crt-p, valitude x4 crt-p, visionist crt-... GUIDANT CORP. P030005 S206 12/11/2020
etrinsa 8 hf-t, epyra 8 hf-t, and eluna 8 hf-t BIOTRONIK, INC. P070008 S120 12/01/2020
edora 8 hf-t qp, edora 8 hf-t, evity 8 hf-t qp, ev... BIOTRONIK, INC. P070008 S119 11/17/2020
valitude, valitude x4, visionist and visionist x4 GUIDANT CORP. P030005 S204 11/16/2020
home monitoring system version 3.48 BIOTRONIK, INC. P070008 S117 11/05/2020
anthem, allure, allure quadra, quadra allure mp, q... Abbott Medical P030035 S182 10/26/2020
invive, intua, visionist, valitude - crt-p resynch... GUIDANT CORP. P030005 S200 10/22/2020
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