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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/BRADYCARDIA REFERENCE/PATIENT MANUAL
Classification Nameprogrammer, pacemaker
Generic Namepacemaker programmer software
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP830045
Supplement NumberS072
Date Received09/22/2000
Decision Date10/02/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the users manuals for the integrity afx dr model 5342 and sr model 5142.
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