Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI, INGEVITY+

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Essentio, Proponent and Accolade MRI Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI PROPONENT MRI and ACCOLADE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY NON-MRI LEAD & INGEVITY MRI LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MRI Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade MRI Pacemakers, Essentio MRI, Proponent MRI, Accolade MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Essentio, Proponent, and Accolade MRI Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Active Fixation INGEVITY Leads

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 ·Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY + Leads - Active Fixation