Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S

MODEL 430-07 ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

FDA 510(k)

FDA Class 3 ·Cardiovascular

TIR/TIJ AND POLYROX

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL BJ44 AND BJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2500 AFP, MODEL L5KAP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D