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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/ENTITY DR,DC,SR
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS066
Date Received07/06/1999
Decision Date07/27/1999
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the firmware of the affinity series of pulse generators.
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