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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, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS101
Date Received08/30/2004
Decision Date11/22/2004
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) a firmware modification to the identity/identity adx family of pacemakers to correct a potential condition that would result in hardware back-up vvi pacing; and 2) a component design change to identity/identity adx, infinity and integrity family of pacemakers modifying the printed circuit board used to connect the feedthrough to the pacemaker circuitry.
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