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ST. JUDE MEDICAL, INC. SIM CONFIRM (DM2102) 1CM 5 10(k) PREMARKET NOTIFICATION SECTION 5 Applicant: St. Jude Medical, Inc. 645 Almanor Avenue Sunnyvale, CA 94085 USA Phone: (408) 738-4883 Fax: (408) 735-8750 Contact Person: Michael McSweeney Regulation Number: 21 CER 870.2800 Regulation Name: Implantable Cardiac Monitor
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FDA Registration Number: 3008494315. US Agent: Lydia Telep / St. Jude Medical. Phone: +1- (818)-493-3532 E-Mail: ltelep sjm.com. 13 Products/Services (Click for related suppliers) • Automatic Implantable Cardioverter Defibrillator. • Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (FDA Code: NIK)
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expert consultation for urgent interrogation and/or surgery. Table 1 (Continued) Manufacturer Phone number Programmers Radiopaque logo MicroPort‡ 1(855) 877-3899 “ELA” or “S..” or “MS..” See reference 6 for more radiographic illustrati
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Company Name: ST. JUDE MEDICAL, INC. Primary DI Number: 05414734507073 Issuing Agency: GS1 Dual-chamber implantable pacemaker, rate-responsive A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and
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At American Bright Works we understand the importance of medical device technology in the current health care industry. Our experience with implantable devices includes various finishing requirements on orthopedic bone screws and plates, pacing components and dental implants along with a wide variety of surgical tooling.
Creating an artificial implantable kidney would be an epic advance in medicine and could address a chronic shortage of donor kidneys needed for transplant.
Schematic design for an implantable artificial kidney device, using iliac vessels for arterial blood inflow and venous return, with ultrafiltratate draining into the bladder. Courtesy Shuvo Roy, UCSF.