ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4951P

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODELS 5069/5071 MYOCARDIAL PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX/MINIX ST PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 5866-45 SIZING SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT CARDIAC PACING LEADS AND ADAPTORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20E

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 250 DEFIBRILLATOR/MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 300

FDA 510(k)

FDA Class 3 ·Cardiovascular

FAST-PATCH

FDA 510(k)

FDA Class 3 ·Cardiovascular

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·HEART LASER CO2 TMR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR, DR MRI and SR MRI IPG

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane® Eyelight

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, and Viva CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA)