STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTILITH 2 PULSE GENERATOR 1141 & 2141

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS MODELS 4033 AND 4034

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTILITH 3 MODELS 1350, 3350, 1370, 3370

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AFP-EIA

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ER-EIA MONOCLONAL

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·PGR-EIA MONOCLONAL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ELA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL'S REPLY PACEMAKERS