Profile: St.Jude Medical, Inc. delivers implantable bradycardia, cardiac surgical, electrophysiology, implant cardiac monitors, repair, tachycardia, tissue valves, spinal cord stimulation, patient care network, mechanical valves, cardioverter defibrillators, pacemakers, electrophysiology catheters, vascular closure devices, heart valve replacement & repair products and neurostimulation devices. Cardiac catheterization is a common diagnostic test performed to evaluate the condition of the heart muscle, valves & vessels, which enables the physician to see how effectively the heart is pumping and to determine if there are any narrowed blood vessels. Our Epicor Cardiac Ablation System uses the control and precision of High Intensity Focused Ultrasound (HIFU) energy to replicate proven ablation lesion sets epicardially, without the need to place the patient on a heart-lung bypass machine. Our Epicor Ablation Control System ACS is designed for consistent, effective delivery of HIFU energy. It features an intuitive user interface, single-button control of ablation cycles, and convenient real-time monitoring and display of parameters such as power delivery and temperature. Three generators provide consistent three-phased ablative energy through all layers of tissue, without concerns for tissue depth or the need for fat dissection.

The company is ISO 9001, ISO 9002, CE certified. NYSE:STJ (SEC Filings)

FDA Registration Number: 2017865

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• Adjunctive EP Devices

• Angioplasty Guidewire

• Annuloplasty Rings (FDA Code: KRH / 870.3800) An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

• Artery Vascular Clamp (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (FDA Code: NIK)

• Automatic Implantable Cardioverter-defibrillator (FDA Code: LWS)

• Biological Cardiac Valve Prosthesis (FDA Code: DYE / 870.3925) A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

• Cardiac Ablation Percutaneous Catheter (FDA Code: LPB)

• Cardiac Ablation Percutaneous Catheter For Treatment Of Atrial Flutter (FDA Code: OAD)

• Cardiac Catheters

• Cardiac Pacemaker Generators

• Cardiac Resynchronization Therapy Device (Cardiology, Vascular Surgery)

• Cardiac Valve Prosthesis

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Catheter Accessories (FDA Code: KGZ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Introducers, MULLINS

• Catheter Introducers, Mullins Design

• Catheter Stylets (FDA Code: DRB / 870.1380) A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

• Catheter Tip Blood Pressure Transducer (FDA Code: DXO / 870.2870) A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

• Chronic Catheter Accessories

• CRT with ICD

• Cryo Ablation Catheters

• Delivery Catheters

• Diagnostic EP Consoles

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Drug Wound Dressing (FDA Code: FRO)

• Drug-Eluting Permanent Defibrillator Electrodes (FDA Code: NVY)

• Dual Chamber (Biventricular) ICD

• Dual Chamber Implantable Heart Pacemaker

• Electrocardiograph Transmitter/Receiver System (FDA Code: DXH / 870.2920) A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

• Electrode Recording Catheter (FDA Code: DRF / 870.1220) An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

• Electrophysiology Catheters

• External Pacemaker Pulse Generator (FDA Code: DTE / 870.3600) An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing sytem until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

• External Programmable Pacemaker Pulse Generator (FDA Code: JOQ / 870.1750) An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.

• Foley Catheter Introducer

• For Ablation Of Cardiac Tissue Surgical Device (FDA Code: OCL / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Guide Catheter, Delivery

• Guidewire Catheter (FDA Code: DQX / 870.1330) A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Guidewires, Hydrosteer

• Heart Pacemaker Generators

• Heart Valve Prosthesis Holder (FDA Code: DTJ / 870.3935) A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

• Heart Valve Prosthesis Sizer (FDA Code: DTI / 870.3945) A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.

• Heart Valve Repair Products

• Heart-Valve, Non-Allograft Tissue (FDA Code: LWR)

• Implantable Cardiac Event Recorder (Without Arrhythmia Detection) (FDA Code: MXC / 870.2800) A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.