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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 U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS
Classification Nameprogrammer, pacemaker
Generic Namecardiac pacemaker
Regulation Number870.3700
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP880086
Supplement NumberS081
Date Received11/16/2000
Decision Date12/12/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pulse generator models integrity u dr model 5336 and sr model 5136 pulse generators.
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