System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Protecta ICD, Pro

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Pro

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·RelayPro Thoracic Stent-Graft System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads