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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceCONTACK RENEWAL TR
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS004
Date Received10/21/2004
Decision Date11/19/2004
Product Code DTB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
  We welcome your comments and feedback about Devices@FDA.
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