Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

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

FDA Pre-Market Approval

FDA Class 3 ·OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead

BIPOLAR LEADS, DISP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 493-03 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC #4951

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERM. INPLANT ENDOCARD. PAC. LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

CORDIS MULTIFILAR PERVENOUS VENTRIC. LD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELECTRODE LEAD CONSTRUCTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE TLE (TRAEBECULAR LODGING ELEC

FDA 510(k)

FDA Class 3 ·Cardiovascular

TYPE YC ENDOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular