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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.
DeviceAV PLUS DX, MODEL 1368
Classification Nameprogrammer, pacemaker
Generic Nameprogrammer, pacemaker
Regulation Number870.3700
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS090
Date Received12/04/2002
Decision Date01/22/2003
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the shelf life of st. Jude medical steroid-eluting bradycardia leads.