Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC ICDS

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM PULSE GENERATORS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL MINI SINUS IMPLANT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel® Contour Sinus Implant

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel and Propel Mini Sinus Implants

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL MINI SINUS IMPLANT, 6011

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL MINI SINUS IMPLANT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL SINUS, MINI SINUS IMPLANT.

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel, Propel mini and Propel Contour Sinus Implants

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL, PROPEL MINI and PROPEL CONTOUR

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·INTERSECT ENT PROPEL MINI SINUS IMPLANT