Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·NEO 2101.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·NEO 2401.U/1

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·NEO 2401.U/1

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·NEO 2401.U/1

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·NEO 2401.U/1

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2302.U, NEO 2302.U

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PSW 2303.U, NEO 2303.U

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 2301.U, NEO 2301.U