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Pulse Generator Pacemaker - Articles

CDRH Transparency: 515 Program Initiative Project Status Update - Implantable Pacemaker Pulse Generator Step 3 by FDA Posted Fri 29 Jul 2011 12:00am Step 1: FDA collects existing information Step 2: FDA assesses the risks and benefits Step 3: FDA issues proposed rule, which proposes classification of device type into Class I, II, or III Step 4: FDA receives and reviews comments provided Step 5: FDA issues final rule, which finalizes classification of dev ... Read on »
Federal Register: Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator by FDA Posted Fri 22 Jun 2012 12:00am The FDA is...The FDA is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. Read on »
Letter to Industry about Import Entry Review Process by FDA Posted Thu 24 Mar 2011 12:00am Dear Official Correspondent/United States Agent, The United States Food and Drug Administration (USFDA), Center for Devices and Radiological Health (CDRH), is increasingly concerned with the number of imported medical devices that do not have sufficient entry data to allow the USFDA to make a prompt admissibility decis ... Read on »
EBR Systems and Cambridge Consultants Developed First Wireless Pacing System–Pacemakers Without Leads And Wireless All Con by Medical Quack Patient ExpertHealth Maven Posted Tue 15 Nov 2011 10:31pm One of the riskiest components of a pacemaker are the leads, the series of wires led through key veins into the heart and then connected to electrodes to control the pacemaker itself. This complicated surgery brings a high level of additional risk.  The leads are also suspected to be one of pacemakers’ critical failure points.  This problem ha ... Read on »
Implant used to treat urinary incontinence by Allanda .. Patient Expert Posted Wed 01 Aug 2012 6:23pm The Urodynamics unit at the Hamad Medical Corporation’s Urology Department six months ago introduced the Intersim advanced sacral neuro-modulation Implant featured a few weeks ago. The surgical device acts like bladder pacemaker to treat those suffering from urinary incontinence . “We have introduced the new treatment to help our patients w ... Read on »
How About A Biological Pacemaker? by Ng Peng Hock Patient Expert Posted Mon 11 Mar 2013 1:07am Pacemakers are, small devices placed in the chest or abdomen, used to treat arrhythmias. Arrhythmias are problems about the rate or rhythm of the heartbeat: the heart can beat too fast, too slow or with an irregular rhythm. While most arrhythmias are harmless, some can be serious or even life threatening. The inability of the heart to pum ... Read on »
What is a Pacemaker? by ShapeUp .. Posted Sun 24 Aug 2008 1:49pm ANNOUNCER: Everyone has heard of pacemakers, but most people don't know what an important role a pacemaker can play in maintaining a healthy heart and lifestyle. MELANIE GURA, MSN, RN: An artificial pacemaker is a small, battery-operated device that can actually take over the role of the heart's electrical system when needed. It consists of the ... Read on »
FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams by Health: Hearsay & Headlines Posted Tue 08 Feb 2011 12:00am /PRNewswire/ -- The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams. Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field ... Read on »
New Pacemaker Can Be Used Safely During MRI Exams by MedNews Patient Expert Posted Tue 08 Feb 2011 3:23pm The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams. Pacemakers are s ... Read on »
FDA Approves 1st Pacemaker Designed to Work Safely during Some MRI Exams by Medline Plus Posted Tue 08 Feb 2011 6:20pm FDA approves 1st pacemaker designed to work safely during some MRI exams The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams. Pacemakers are surgically implanted medical devices that generate electri ... Read on »