Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI LEAD, INGEVITY Non-MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead/ Revo MRI SureScan IPG

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead, Revo MRI SureScan IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MRI

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI and Amplia MRI Quad CRT-D SureScan, Compia MRI and Compia MRI Quad CRT-D SureScan and Claria MRI and Claria M

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Montage MRI Spinal Cord Stimulator (SCS) Systems

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEMS