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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.
 
DeviceADDVENT/AV PLUS DX
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS064
Date Received07/01/1999
Decision Date07/23/1999
Product Code
DXY[ Registered Establishments with DXY ]
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 an extension of the approved shelf life for the device including pulse generator models 2060bl and 2060lr (12 to 18 months), and the model 1368 single pass lead (12 to 24 months).
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