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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.
 
Trade NameADDVENT/AV PLUS DX
Classification Nameprogrammer, pacemaker
Generic Nameimplantable pulse generator and permanent electrode
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS064
Date Received07/01/1999
Decision Date07/23/1999
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
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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