Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM RVDR01

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·AATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System: MC1AVR1; MC2AVR1; MC1VR01; MC2VR01

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/RETRACTABLE PACING LEADS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Fineline II Sterox, Sterox EZ pace / sense leads

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP PACING LEADS

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System and Micra AV TPS

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

FDA Pre-Market Approval

FDA Class 3 ·ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD,LEFT VENTRICULAR PACING LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System, Micra AV Application Software

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, AT501 DDDRP PACING SYSTEM IPG

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

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYS. MODEL 3039 FUNCTION PACK

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD