Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILITATION CARTHETERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Akreos Posterior Chamber Intraocular Lens

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

FDA Pre-Market Approval

DISHLER EXCIMER LASER SYSTEMS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION CATHETER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED IMPLANTABLE INFUSION PUMP

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II, SECURA AND VIRTUOSO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO II, CONSULTA AND MAXIMO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE