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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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51 to 60 of 151 Results
PMA Number P070008 Decision Date To 04/28/2024
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EVIA HF-T, ENTOVIS HF-T, STRATOS LV, COROX OTW, CE... BIOTRONIK, INC. P070008 S056 10/21/2014
Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 H... BIOTRONIK, INC. P070008 S123 04/14/2021
Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 H... BIOTRONIK, INC. P070008 S127 07/21/2021
Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Eni... BIOTRONIK, INC. P070008 S094 02/12/2019
EVIA/ENTOVIS PULSE GENERATORS BIOTRONIK, INC. P070008 S011 05/07/2010
Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, E... BIOTRONIK, INC. P070008 S154 10/24/2023
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 BIOTRONIK, INC. P070008 S012 10/22/2009
Home Monitoring System Version 3.48 BIOTRONIK, INC. P070008 S117 11/05/2020
Home Monitoring System Version 3.56.0 BIOTRONIK, INC. P070008 S147 05/11/2023
LEAD FIXATION SLEEVE BIOTRONIK, INC. P070008 S013 10/28/2009
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