Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRl IPG, Advisa SR MRl IPG, Astra S DR MRl IPG, Astra S SR MRl IPG, Astra XT DR MRl IPG, Astra

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRl

SMARTLANK WIRELESS, MODEL 001970

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRl CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 90 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Hip System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEDITEC MEL 80 EXCIMER LASER SYSTEM

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type-1 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate 4000 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·ExAblate Neuro Thalamotomy