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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.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS156
Date Received10/24/2007
Decision Date12/12/2007
Product Code
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 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.