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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 FAMILY
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS144
Date Received03/13/2007
Decision Date03/29/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes for the vitality and contak renewal families of defibrillators: 1) require the reed switch component supplier to expose 100% of the components to a high magnetic field condition of minimum of 30mt, 10 cycles with 1 second duration prior to shipping to guidant. 2) apply an enhanced quality test of 30mt through 30 cycles and verify the reed switch is open after removing the device from the magnetic field, to all devices currently held under a stop action notice (san).
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