Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC10 & AC20 IOLS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF CURRENT, ATLAS, EPIC, CONVERT, CURRENT, & FORTIFY ICD'S

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·TORAY SOFT CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulato

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·4598MEDTRONIC ATTAIN ABILITY MODEL 4196, ATTAIN PERFORMA S MRI SURESCAN LEAD MODEL

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft/Medtronic Interbody Fusion Device

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Simplicity Delivery System, SmartLOAD Delivery Technology, TECNIS iTec Preloaded Delivery System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 925, 2040, 2041, 6564

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODELS 8416 AND 8418 LEGEND PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR