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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 NameAFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS156
Date Received10/24/2007
Decision Date12/12/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two corrective fixes to address a hardware issued that can leave the crt-d and icd systems listed above in a post-sense refractory state. For devices that are already implanted and/or already manufactured, changes will be made to the programmer software. During a patient follow-up visit, the programmer will interrogate the device and download firmware ram code to correct the anomalous condition if it occurs. For new devices, a modification has been made to the sio2 chip hardware to check the sense refractory state every two seconds and end it if appropriate.
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