Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II FAMILY OF PULSE GENERATORS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED PROGRAMMABLE INFUSION PUMPS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PUMP/INTRATHECAL CATHETERS/INTRATHECAL CATHETERS/PUMP/SPINAL SEGMENT REVISION KITS/SUTURELESS PUMP

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4

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 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead; Attain Performa Lead

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 ·TRANSVENE CS/SVC LEAD

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen® LPS-Flex/LPS Mobile Bearing Knee System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Evolut FX Delivery Catheter System