MEDICAL MULTILITH PULSE GENERA-1140

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS S MODEL 4121 AND 4124 PACEMAKERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTILITH PULSE GENERATORS, 1141 & 2141

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH PULSE GENERATOR VVI #7542

FDA 510(k)

FDA Class 3 ·Cardiovascular

LEAD MODELS MUM 1260, MUM 1290

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS

MAXIMA FILTERED HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System