Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PULSE GENERATOR

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PCD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION PUMPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX S AND LINOX T ICD LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·HOME MONITORING SERVICE CENTER 3 - VERSION 3.6

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX LEAD/CAPSUREFIX LEAD/CAPSUREFIX NOVUS/PIROUET

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.5 with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G Insulin Pump

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P