Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY PACEMAKERS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION & ML8 CORONARY STENT SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

ELA MEDICAL UNILITH 7540 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSE GENERATOR MODEL 61 AND 128

FDA 510(k)

FDA Class 3 ·Cardiovascular

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