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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 24 Results
productcode MRM PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Blind plug BS IS4 BIOTRONIK, INC. P050023 S111 08/16/2017
Defibrillator, Implantable, Dual Chamber, Automati... BIOTRONIK, INC. P050023 S107 05/06/2017
DEFIBRILLATOR, IMPLANTABLE, DUAL CHAMBER, AUTOMATI... BIOTRONIK, INC. P050023 S106 01/31/2017
Inventra / Iperia / Itrevia BIOTRONIK, INC. P050023 S108 05/06/2017
IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-... BIOTRONIK, INC. P050023 S101 02/08/2017
Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4 BIOTRONIK, INC. P050023 S109 08/02/2017
Lumos DR-T/VR-T BIOTRONIK, INC. P000009 S072 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. BIOTRONIK, INC. P000009 S071 05/06/2017
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