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Pacemaker Generator - 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 »
Single gene Tbx18 can generate cardiac pacemakers by EyeDrD Posted Wed 26 Dec 2012 8:30am Commentary: Truly remarkable that future of medicine is changing for the better thanks to the bench works of the dedicated scientists searching for new discoveries. Scientists have successfully transformed guinea-pig heart-muscle cells into pacemaker cells, paving the way for a … Continue reading → From: Eye Dr DeLengocky Read on »
Engineered Biological Pacemakers by nih.gov Posted Mon 20 Dec 2010 7:00pm Description of Invention: A common symptom of many heart diseases is an abnormal heart rhythm or arrhythmia. While effectively improving the lives of many patients, implantable pacemakers have significant limitations such as limited power sources, risk of infections, potential for interference from other devices, and absence ... 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 »
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 »
Surgeons Implant Brain PACEMAKER in Alzheimer's Patient by Bob DeMarco Patient Expert Posted Wed 05 Dec 2012 1:12pm Recent failures in Alzheimer’s disease trials using drugs such as those designed to reduce the buildup of beta amyloid plaques in the brain have sharpened the need for alternative strategies to treat Alzheimer's. One strategy now being tested for the first time is the brain pacemaker. Alzheimer's Reading Room Will a brain pacem ... Read on »
Accent RF Pacemaker Using Wireless Technology From St. Jude – First Implant Successful With A Pacemaker Sending Data to EHRs and by Medical Quack Patient ExpertHealth Maven Posted Mon 14 Dec 2009 8:03am 1 Comment With no additional interaction from the patient, the device automatically sends data to the patient’s physician.  The first implant was completed in Canada.  Data is normally sent when the patient is sleeping.  I have written here quite a bit about the Merlin system from St. Jude as it has developed through FDA approval all the way to integration ... 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 »
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 »