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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 29 Results
productcode NKE PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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valitude crt-p; valitude x4 crt-p; visionist GUIDANT CORP. P030005 S173 02/08/2018
stratos, evia, entoivs, eluna 8, epyra 8, and etri... BIOTRONIK, INC. P070008 S097 10/22/2018
stratos lv crt-p / stratos lv-t crt-p / corox otw ... BIOTRONIK, INC. P070008 S088 02/15/2018
siello t 53; siello t 60; siello jt 45; siello jt ... BIOTRONIK, INC. P070008 S096 08/27/2018
pulse generator, pacemaker, implatable, with cardi... BIOTRONIK, INC. P070008 S090 12/19/2018
psw 1801.u BIOTRONIK, INC. P070008 S092 08/15/2018
invive, intua, visionist, valitude GUIDANT CORP. P030005 S172 03/26/2018
invive, intua, valitude, valitude x4, visionist, v... GUIDANT CORP. P030005 S178 11/16/2018
invive crt-p, intua crt-p, valitude crt-p, visioni... GUIDANT CORP. P030005 S176 07/27/2018
ingenio crt-p devices (invive, intua), ingenio 2 c... GUIDANT CORP. P030005 S171 02/02/2018