Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL DEFECT OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV FOR ASTRID

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY DS ICD SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-4 DEFIBRILLATION LEAD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUTURE SLEEVE ACCESSORY

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

FDA Pre-Market Approval

FDA Class 3 ·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Dynagen™ Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen™ Models: D010, D011, D012, D013, D140, D141, D14

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q and RES-Q MICRON ICD and ICD Lead Family