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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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stratos, evia, entoivs, eluna 8, epyra 8, and etri... BIOTRONIK, INC. P070008 S097 10/22/2018
siello t 53; siello t 60; siello jt 45; siello jt ... BIOTRONIK, INC. P070008 S096 08/27/2018
corox otw bp; corox otw-l bp; corox promri otw bp;... BIOTRONIK, INC. P070008 S095 08/09/2018
evia hf /hf-t; entovis hf/ hf-t ; edora 8 hf-t; en... BIOTRONIK, INC. P070008 S093 06/13/2018
psw 1801.u BIOTRONIK, INC. P070008 S092 08/15/2018
evia hf, hf-t, entovis hf, hf-t, edora 8 hf-t, eni... BIOTRONIK, INC. P070008 S091 06/19/2018
pulse generator, pacemaker, implatable, with cardi... BIOTRONIK, INC. P070008 S090 12/19/2018
corox otw bp/otw-s bp; corox otw-l bp/promri otw-l... BIOTRONIK, INC. P070008 S089 02/21/2018
stratos lv crt-p / stratos lv-t crt-p / corox otw ... BIOTRONIK, INC. P070008 S088 02/15/2018
allure, allure quadra and quadra allure mp Abbott Medical P030035 S176 12/11/2018