Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 DR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Lumos DR-T/VR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS DR-T PULSE GENERATOR

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;