Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Inflatable Penile Prosthesis (IPP) with and without InhibiZone, Ambicor IPP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI/S DR/S VR/XT DR/XT VR, Intrinsic 30, Marquis VR, Maximo II, Protecta/Protecta VR/XT, Secura/Secura DR, Virtuo

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Express Monitor

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta, Syncra, and Viva CRT-Ps

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·INFINITY FAMILY OF DBS IPGS AND DBS EPG

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·mySCS™ GO Therapy Controller App