Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D & PARADYM RF CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO ICD MODELS 614 AND 615

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF VR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY (V2) AND ESPRIT DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY/ESPRIT SR/DR PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) and Orchestra Plus Link

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·Star S4 IR Excimer Laser System

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

FDA Pre-Market Approval

FDA Class 3 ·Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG