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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 HE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS087
Date Received10/03/2005
Decision Date12/21/2005
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of inspection tests, materials, alternate suppliers and manufacturing instructions.
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