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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 NumberS150
Date Received06/20/2007
Decision Date07/12/2007
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 use of the circuitry use din the analog chip in the victory/zephyr family of devices in the analog chip used in the identity and identity adx family of devices, and for resizing the sense and iegm gain capacitors.