Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Peripheral Self-Expanding Nitinol Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD,

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS/CRT-DS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD

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

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75 UP STEROID, COROX OTW 85 UP STEROID

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS & LUMOS FAMILIES OF ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·NEO 2101.U