Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Patient Management System/ LATITUDE NXT G2 Communicator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF;

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Neutrino™ NxT HF, Entrant™ HF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Release 7.3

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT RELEASE 4.1.1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT Release 7.1.5

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT Release 5.0

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Patient Management System, LATITUDE™ Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NXT Syst