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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 5346
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP830045
Supplement NumberS078
Date Received09/05/2001
Decision Date10/02/2001
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3307 v2. 4. 1a programmer software which allows for the integrity afx dr model 5342 and integrity u dr model 5336 to access the dynamic atrial overdrive (dao) and advanced hysteresis features.
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