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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/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS110
Date Received10/11/2005
Decision Date01/31/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate organic feedthru substrate to be used in the affinity, entity, identity, identity adx, integrity and verity families of pulse generators.
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