FDA Pre-Market Approval

MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·QUADRIPOLAR PACING PAS (QUAD PAS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRT IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

FDA Pre-Market Approval

BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG

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

FDA Pre-Market Approval

FDA Class 3 ·MT PAS ACUITY X4

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS LACROSSE TM PTCA CATHETER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-PCS MONOFOCAL LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION HP PTCA CATHETER

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN