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

FDA Pre-Market Approval

FDA Class 3 ·Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello/Solia S Leads Tip

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent, Implantable

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Drug-Eluting Permanent Defibrillator Electrodes

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER TLINE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137

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

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 2302.U, NEO 2302.U