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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.
 
DeviceCONTAK RENEWAL TR
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS003
Date Received06/21/2004
Decision Date08/06/2004
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PROGRAMMER SOFTWARE APPLICATION MODEL 2865 VERSION 1.9.
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