Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS/CAPSURE/CAPSURE SENSE LEADS/VITATRON EXCELLENCE PS+/VITATRON CRYSTALLINE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead/CapSure SP Z Lead/CapSure Z Novus Lead/Vitatron Impulse II Lead

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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE Family of Endocardial Pacing Leads

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

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ANCHORING SLEEVE KIT, SELECTSECURE LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFIx Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chrominum Coronary Stent System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD, 4195

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C