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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 Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS095
Date Received08/05/2003
Decision Date08/15/2003
Product Code
DXY[ Registered Establishments with DXY ]
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 modifications to the firmware of the adx family of pulse generators and for programming software model 3307 v4. 4. 2a to implement the modified firmware in implanted devices.