Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL 3 RF CONTAK & RENEWAL PG, LIVIAN CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 RF AND LIVIAN FAMILIES OF CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LIVIAN/RENEWAL 3/RENEWAL 3RF/RENEWAL 3 AVT PULSE GENERATOR FAMILIES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF MARINR/NTC/5RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera™ System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Dexcon G5 Mobile Continuous Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·NuDel Delivery System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM