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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 24 Results
productcode MRM PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
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Pacemaker ICD CRT Non Implanted components. BIOTRONIK, INC. P000009 S071 05/06/2017
Lumos DR-T/VR-T BIOTRONIK, INC. P000009 S072 05/06/2017
Defibrillator, Implantable, Dual Chamber, Automati... BIOTRONIK, INC. P050023 S107 05/06/2017
Inventra / Iperia / Itrevia BIOTRONIK, INC. P050023 S108 05/06/2017
PACEMAKER ICD CRT NON IMPLANTED COMPONENTS BIOTRONIK, INC. P000009 S070 05/04/2017
PACEMAKER ICD CRT NON IMPLANTED COMPONENTS BIOTRONIK, INC. P050023 S105 05/04/2017
Pacemaker/ICD/CRT non implanted components; PSW 16... BIOTRONIK, INC. P000009 S068 05/03/2017
Various models of dual chamber ICDS in the Ilivia,... BIOTRONIK, INC. P050023 S103 05/03/2017
PSW 1601.U Pacemaker/ICD/CRT non implanted compone... BIOTRONIK, INC. P000009 S069 03/24/2017
PSW 1601.U Pacemaker/ICD/CRT non implanted compone... BIOTRONIK, INC. P050023 S104 03/24/2017
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