Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC / VITATRON CARELINK PROGRAMMING OPERATING SYSTEM AND MEDICAL DEVICE APPLICATION SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA FAMILIES/C & T SERIES DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)