Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Eeverolimus-Eluting Platinum Chromium Coronary Stent

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chill II

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II HTD, Blazer Prime HTD

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Atherectomy System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA (LN 6C07)

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6CO6)

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Thrombectomy Catheter

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingevity MRI

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Epic Vascular Self-Expanding Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Emblem S-ICD, Electrode

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM