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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 NameMEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 APPLICATION SOFTWARE
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS008
Date Received08/21/2003
Decision Date02/06/2004
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic insync ii protect model 7295 with model 9992 application software. The device, as modified, will be marketed under the trade name medtronic insync ii protect model 7295 with model 9992 application software and is indicated as follows: the insync ii protect provides ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction <= 35% and a qrs duration >= 130 ms. The insync ii protect device only allows arrhythmias in the vf zone to receive treatment. Arrhythmias in the monitor only zone will not be treated by the device.
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