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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 NameVICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS108
Date Received08/30/2005
Decision Date12/07/2005
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the victory pulse generator models xl dr 5816, dr 5810 and sr 5610.
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