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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 NameVITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS032
Date Received05/27/2003
Decision Date10/22/2003
Product Code
KRG[ Registered Establishments with KRG ]
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 to enable the automatic intrinsic rhythm id algorithm update feature. The device, as modified, will be marketed under the trade name vitality vr/dr/ vitality+ dr aicd systems and the programmer software application model 2857 version 1. 6 and is indicated for use as follows: the vitality vr/dr/ vitality+ dr aice system is indicated for use in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias. In addition, this device is indicated for prophylactic treatment of patients with a prior myocardial infarction and ef <30%.
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