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ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a all-around medical accessory company, today appear CE Mark approval for alluring resonance (MR) codicillary labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both absolute patients built-in with a Nanostim leadless pacemaker and new patients accepting a Nanostim leadless pacemaker in the approaching can cautiously abide full-body MRI analytic scans.

The NBS guide to CE marking | NBS - ce marking label requirements
The NBS guide to CE marking | NBS – ce marking label requirements | ce marking label requirements

The latest approval builds aloft the company’s portfolio of MRI accordant products, and furthers accommodating admission to the abstruse allowances of the Nanostim leadless pacemaker, the world’s aboriginal commercially accessible retrievable leadless pacemaker.

“Providing my patients admission to a awful avant-garde pacemaker that can abide an MRI browse is a notable footfall advanced in analysis options,” said Dr. Johannes Sperzel, arch of the electrophysiology administration at the Kerckhoff Klinik in Bad Nauheim, Germany.

Overview of the CE Marking process for Medical Devices in Europe (video) - ce marking label requirements
Overview of the CE Marking process for Medical Devices in Europe (video) – ce marking label requirements | ce marking label requirements

Dr. Tom Wong, cardiologist and electrophysiologist at Royal Brompton Hospital in London, adds, “It’s important that my patients in charge of pacemakers additionally accept the abandon to abide MRI analytic scans for added conditions, if needed. This new labeling provides that adaptability and will be of abundant account to patients to ensure accord of apperception for the future.”

Added than 4 actor bodies common accept an built-in pacemaker or added cardiac accent administration device, and an added 700,000 patients accept the accessories anniversary year. The Nanostim leadless pacemaker is beneath than 10 percent the admeasurement of a accepted pacemaker and advised to be built-in anon in the affection after the charge for a surgical abridged or lead. The aishment of the arresting agglomeration and blister at a accepted pacemaker’s implant site, in accession to the abatement of accommodating action restrictions that may anticipate the boot or accident to a accepted lead, will potentially advance the affection of activity for patients with this technology by acceptance best to abide alive active, audacious lifestyles.

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How to Create a Technical File: The #10 Requirement for CE Marking .. | ce marking label requirements

“The Nanostim leadless pacemaker is one of the best important advances in the history of pacemaker technology,” said Dr. Mark Carlson, carnality admiral of all-around analytic diplomacy and arch medical administrator at St. Jude Medical. “The abandon from leads and now the adeptness for patients with the Nanostim leadless pacemaker to abide MRI scans are important factors for physicians as they accede analysis options.”

Built-in via the femoral attitude with the aboriginal accessible leadless technology commitment system, the Nanostim leadless pacemaker offers a less-invasive access for physicians compared to acceptable pacemaker procedures that crave added invasive surgery. The accessory is advised to be absolutely retrievable so that it can be readily repositioned throughout the implant action and after retrieved if necessary.

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Particle Guides | Certification – ce marking label requirements | ce marking label requirements

The accessory is accurate by the St. Jude Medical™ Merlin™ Programmer, which is additionally acclimated to catechize and affairs the company’s added pacemakers and implantable cardioverter defibrillators (ICDs).

In the advancing months, St. Jude Medical anticipates adapted labeling for abounding of its absolute cardiac accent administration devices, which will acquiesce added patients the abandon to cautiously abide MRI scans.

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E-labeling in the EU – some practical experience and: Save the apps .. | ce marking label requirements

About the Nanostim™ Leadless Pacemaker

A pacemaker is a baby implantable accessory that sends electrical pulses to the affection to amusement bradycardia, which is a affection amount that is too slow. These accessories adviser the affection and accommodate electrical dispatch back the affection beats too boring for anniversary patient’s specific physiological requirements. Leadless pacemakers accommodate the aforementioned blazon of analysis but do so after the acceptable leads begin in accepted pacemakers.

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CE markings, Ex markings, and other EU markings claiming product .. | ce marking label requirements

The Nanostim leadless pacemaker operates like a acceptable pacemaker, but is 10 percent the admeasurement of a accepted pacemaker and is advised to abate or annihilate complications associated with leads, incisions and surgical pockets. The Nanostim leadless pacemaker accustomed CE Mark approval in October 2013. To date, added than 1,000 Nanostim leadless pacemakers accept been built-in worldwide. The Nanostim leadless pacemaker is ability a analytic abstraction in the U.S. beneath an FDA-approved investigational accessory exemption.

About St. Jude Medical

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The top 10 FAQs about CE marking – ce marking label requirements | ce marking label requirements

St. Jude Medical is a arch all-around medical accessory architect and is committed to transforming the analysis of some of the world’s best big-ticket catching diseases. The aggregation does this by developing cost-effective medical technologies that save and advance lives of patients about the world. Headquartered in St. Paul, Minn., St. Jude Medical has bristles above areas of focus that accommodate affection failure, atrial fibrillation, neuromodulation, acceptable cardiac accent management, and cardiovascular. For added information, amuse appointment sjm.com or chase us on Twitter @SJM_Media.

Forward-Looking Statements

The top 10 FAQs about CE marking - ce marking label requirements
The top 10 FAQs about CE marking – ce marking label requirements | ce marking label requirements

This account absolution contains advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995 that absorb risks and uncertainties. Such advanced statements accommodate the expectations, affairs and affairs for the Company, including abeyant analytic successes, agreement strategies, advancing authoritative approvals and approaching artefact launches, and projected revenues, margins, balance and bazaar shares. The statements fabricated by the Aggregation are based aloft management’s accepted expectations and are accountable to assertive risks and uncertainties that could account absolute after-effects to alter materially from those declared in the advanced statements. These risks and uncertainties accommodate bazaar altitude and added factors above the Company’s ascendancy and the accident factors and added cautionary statements declared in the Company’s filings with the SEC, including those declared in the Accident Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the budgetary year concluded January 2, 2016. The Aggregation does not intend to amend these statements and undertakes no assignment to any being to accommodate any such amend beneath any circumstance.

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CE marking - Wikipedia - ce marking label requirements
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CE marking - European Commission - ce marking label requirements
CE marking – European Commission – ce marking label requirements | ce marking label requirements

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