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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 NameIDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL
PMA NumberP880086
Supplement NumberS239
Date Received02/05/2014
Decision Date03/04/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the wire bond process verification frequency utilized for the hybrid assemblies of the devices.
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