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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 FAMILY OF PULSE GENERATORS
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS079
Date Received10/16/2000
Decision Date11/21/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a layer of kapton tape (a polyimide film) to the edge side of the devices' battery case of the affinity family of pulse generators.
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