Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG AND ADVISA DR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·RELIATY/MODEL 3145 PACING SYSTEM ANALYZER

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH ENHANCED MATRIX)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA, RELIA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON AND PHOENIX PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ENDURITY CORE FAMILY OF PACEMAKER DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra