Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL'S REPLY PACEMAKERS

ELA MEDICAL UNILITH PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELA MEDICAL ANATEC HOLTER SCANNER

FDA 510(k)

FOCUS T41,T41F,T43, T43F,T44F

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL RATE-RESPONSIVE PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

ELA MEDICAL UNILITH 7540 PULSE GENERATOR

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

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELA MEDICAL PACING LEAD MODEL PMA 860

FDA 510(k)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)

FDA 510(k)

FDA Class 1 ·Dental

OPUS MODEL 4001

FDA 510(k)

FDA Class 3 ·Cardiovascular

FOCUS J81F, J83F, J41F, J43F PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEAD #PMA F 860

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066

FDA 510(k)

FDA Class 3 ·Cardiovascular