Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MERIDIAN/DISCOVERY FAMILY OF IMPLANTABLE PACEMAKERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 CORONARY STENT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·XILLIX-LIFE-LUNG

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA THROMBECTOMY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK MINI VISION CORONARY STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI/SPIROFLEX/SPIROFLEX VG/DISTAFLEX THROMBECTOMY SET'S