Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), XIENCE XPEDITION EVEROLIMUS ELUTING

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

FDA Pre-Market Approval

FDA Class 3 ·COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT and PERCIVA CRT-D Res

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform App

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding peripheral Stent with Entrust Delivery Syst

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI THROMBECTOMY SET; ANGIOJET ULTRA SPIROFLEX & SPIROFLEX VG THROMBECTOMY SET; ANGIOLET ULTRA DISTAFLEX

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES; MERLIN PROGRAMMER

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

FDA Pre-Market Approval

FDA Class 3 ·AMPLIA MRI AND AMPLIA MRI QUAD CRT-D SURESCAN MODELS DTMB1D4, DTMB1QQ. COMPIA MRI, CLARIA MRI

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and