Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Lens Optic body diameter cut

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Contact Force Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION IX ABDOMINAL STENT GRAFT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D

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

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 THIRD GENERATION PSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 FREE PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AFP

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE