STELA MODEL BJ44 AND BJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Express LD Premounted Iliac Stent System (ELD)

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

NIDEK DIGITAL KERATOMETER

FDA 510(k)

FDA Class 3 ·Ophthalmic

SOFTRANS INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

AMER. MEDICAL OPTICS DIGITAL KERATO-

FDA 510(k)

FDA Class 3 ·Ophthalmic

CILCO ANTERIOR CHAMBER LENS

FDA 510(k)

FDA Class 3 ·Ophthalmic

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AFP-EIA