Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

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

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT, SETROX S & DEXTRUS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Solia S 45, Solia S 53, Solia S 60, Solia JT 45, Solia JT 53, Solia T 53, Solia T 60

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137,

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Setrox S, Solia S, Safio S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS