Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, Automatic

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non- Crt), Defibrillator, Implantable, Dual-Chamber, Defibrillator, Automatic Im

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VITALIO, ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES