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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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51 to 60 of 163 Results
productcode LWS PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
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Fortify, Fortify Assura Abbott Medical P910023 S390 09/26/2017
ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Au... BOSTON SCIENTIFIC P960040 S403 09/25/2017
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM Abbott Medical P910023 S384 09/21/2017
TVL(TM) LEAD SYSTEM Abbott Medical P950022 S105 09/21/2017
Maximo II ICD, Protecta ICD, Protecta VR ICD, Prot... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S638 09/21/2017
ENDOTAK RELIANCE™, (Defibrillation Leads) BOSTON SCIENTIFIC P910073 S142 09/20/2017
Multi-Application Utility Model, (Non-Implantable ... BOSTON SCIENTIFIC P910077 S161 09/20/2017
RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNA... BOSTON SCIENTIFIC P960040 S395 09/20/2017
S-ICD (Subcutaneous-ICD) Telemetry Wand BOSTON SCIENTIFIC CORPORATION P110042 S083 09/11/2017
Torque Wrench BOSTON SCIENTIFIC CORPORATION P110042 S088 09/11/2017
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