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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 NameINTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS070
Date Received03/13/2000
Decision Date04/06/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the integrity afx dr model and sr model 5142.
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