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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 NamePRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS103
Date Received02/22/2005
Decision Date04/06/2005
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pre-molded header design. The device, as modified, will be marketed under the trade names integrity dr model 5336, identity dr model 5370, identity adx dr model 5380, identity adx vdr model 5480, and integrity adx dr model 5360.
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