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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
Generic Nameimplantable pacemaker Pulse-generator
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS103
Date Received02/22/2005
Decision Date04/06/2005
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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