Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TACTICATH QUARTZ SET

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Carbomedics Prosthetic Heart Valve (CPHV)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·C & T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900/ RELIA/SIGMA/ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPGS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS, GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS