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St. Jude Medical, Inc.


Web: http://www.sjm.com
Address: One Lillehei Plaza, St. Paul, Minnesota 55117-9983, USA
Phone: +1-(651)-483-2000, 800-328-9634 | Fax: +1-(651)-482-8318 | Map/Directions >>
 
 

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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• Implantable Cardioverter Defibrillators
• Implantable Clip (FDA Code: FZP / 878.4300)
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
• Implantable Endocardial Pacemaker Lead
• Implantable Pacemaker Pulse Generator With Cardiac Resynchronization (FDA Code: NKE)
• Implantable Permanent Pulse Generator (FDA Code: NVZ)
• Implantable Spinal Cord Stimulator (FDA Code: GZB / 882.5880)
An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
• Implantable Venous Access Catheter Introducer Kits
• Implanted Peripheral Nerve Stimulator (FDA Code: GZF / 882.5870)
An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
• Internal Atrial Defibrillation Acute Temporary Pacing System (FDA Code: MTE)
• Intravascular Ultrasound Catheter (FDA Code: OBJ / 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.
• Long-Term Vascular Catheter
• Mechanical Aortic Valves
• Mechanical Heart Valve (FDA Code: LWQ)
• Mechanical Mitral Valves
• Medical Magnetic Tape Recorder (FDA Code: DSH / 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.
• Neurostimulation Devices
• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900)
A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.
• Other Catheter
• Pacemaker Cable
• Pacemaker Generators
• Pacemaker Lead
• Pacemaker Lead Adaptor (FDA Code: DTD / 870.3620)
A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.
• Pacemaker Programmer (FDA Code: KRG / 870.3700)
A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker.
• Pacemaker Repair Material (FDA Code: KFJ / 870.3710)
A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.
• Pacemaker Test Magnet (FDA Code: DTG / 870.3690)
A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.
• Paper Chart Recorder (FDA Code: DSF / 870.2810)
A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.
• Patient Transducer and Electrode Cable (FDA Code: DSA / 870.2900)
A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.
• Percutaneous Catheter (FDA Code: DQY / 870.1250)
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
• Percutaneous Catheterization Vessel Dilator (FDA Code: DRE / 870.1310)
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
• Percutaneous Retrieval Device (FDA Code: MMX / 870.5150)
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
• Permanent Cardiac Pacemaker (FDA Code: DTB / 870.3680)
A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
• Permanent Pacemaker Generators
• Platinum Ring Electrode
• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425)
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
• Programmable Implantable Heart Pacemaker (FDA Code: DXY / 870.3610)
An implantable 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 is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human body.
• Pulse Generator Anti-Tachycardia Dual Chamber
• Radiological Image Processing System (FDA Code: LLZ / 892.2050)
A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
• Rate Responsive Implantable Heart Pacemaker
• Single chamber ICD
• Single Chamber Implantable Pulse-Generator (FDA Code: LWO)
• Steerable Catheter (FDA Code: DRA / 870.1280)
A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
• Temperature Ablation Catheters
• Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (FDA Code: NFA / 870.1250)
• Temporary Endocardial Pacemaker Lead
• Temporary Pacemaker Electrode (FDA Code: LDF / 870.3680)
• Tissue Replacement Heart Valves
• Totally Implanted Spinal Cord Stimulator for Pain Relief (FDA Code: LGW)
• Transcatheter Septal Occluders (FDA Code: MLV)
• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560)
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550)
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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