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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTELIGEN ICD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS155
Date Received12/07/2007
Decision Date05/08/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software model 2868, rev. 1. 01 and the model 6628 torque wrench. The device, as modified, will be marketed under the trade name teligen implantable cardioverter defibrillator models e102 and e110, the cognis cardiac resynchronization therapy defibrillator (crt-d) models n118 and n119, application software model 2868, rev. 1. 01 and the model 6628 torque wrench. The cognis crt-d devices are indicated for patients with moderate-to-severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal failure drug therapy, and have left ventricular (lv) dysfunction (ejection fraction <=35%) and qrs duration >=120 ms. The teligen devices are intended to provide ventricular antitachycardia pacing (atp) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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