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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 1/1/2019 Decision Date To 1/1/2020
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anthem, allure/rf, allure quadra/rf family of crt-... Abbott Medical P030035 S177 12/23/2019
valitude crt-p, valitude x4 crt-p, visionist crt-p... GUIDANT CORP. P030005 S192 12/04/2019
valitude crt-p is1/is4 el, visionist crt-p is1 el ... GUIDANT CORP. P030005 S191 11/27/2019
cardiac resynchronization therapy - pacemaker (crt... GUIDANT CORP. P030005 S190 10/29/2019
crt-p resynchronization devices: invive, intua, vi... GUIDANT CORP. P030005 S188 10/18/2019
pulse generator, pacemaker implantble with cardiac... BIOTRONIK, INC. P070008 S108 10/18/2019
stratos lv crt-p and stratos lv-t crt-p, corox otw... BIOTRONIK, INC. P070008 S106 10/04/2019
corox otw bp BIOTRONIK, INC. P070008 S107 10/04/2019
valitude, valitude x4, visionist, and visionist x4... GUIDANT CORP. P030005 S189 09/24/2019
sentus qp lv lead BIOTRONIK, INC. P070008 S104 09/24/2019