Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·9751A SYSTEM ENHANCEMENT MODULE (SEM)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Conductr, RF Contactr, RF Marinr, RF Enhancr II

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE COVER/EXTERNAL PULSE GENERATORS/CABLES/ADAPTOR/SURGICAL CABLE/PATIENT SAFETY CABLES/DISPOSABLE POUCH/SEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM MODEL 7227 ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MICRO JEWEL/JEWEL II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM & GEM II VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System