Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK MONITOR,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG ADDR01, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, ADSR01, ADVDD01;

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY, 8158

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2090 MEDTRONIC CARELINK PROGRAMMER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Visia AF Software SW035 Version 8.1

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead; Vitatron Brilliant S+ VDD Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARE-LINK SMART MONITOR PATIENT READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG; Advisa DR IPG, DR MRI IPG, SR MRI IPG; Astra S DR MRI IPG, S SR MRI IPG, XT DR MRI IPG, XT SR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE