Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY/PLUS LEAD/STRAIGHT LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Pacemakers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm REAL-Time Insulin Pump

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Urinary)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR® Peptide Enhanced Bone Graft