Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Altrua 2, Essentio, Proponent, and Accolade Non-MRI Pacemakers

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet® OrthoPak Non-invasive Bone Growth Stimulator System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Celsius, Celsius RMT, EZ Steer Bi-directional non nav

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALTRUA 2, ESSONTIO, PROPONENT, ACCOLADE, ADVANTIO, INGENIO, VITALIO, Non-MRI Pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0