Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EZE-FIT(TM)

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ABSORBING ANTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262;

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5866-24 PACEMAKER LEAD ADAPTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

INFANT/CHILD REDUCED ENERGY ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED MODELS 8320/8322/8329/8316/8317/8318

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular