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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 NameAFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES
Classification Nameimplantable pacemaker pulse-generator
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS105
Date Received07/26/2005
Decision Date08/25/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a spot laser weld to the resistance weld that bonds the feedthrough wire to the connector wire.
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