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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 NameASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL
PMA NumberP880086
Supplement NumberS240
Date Received03/25/2014
Decision Date04/04/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate burn-in (bi) for the environmental screening used during the manufacture of the devices.
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