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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.
 
DeviceINSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS055
Date Received11/26/2008
Decision Date01/23/2009
Product Code NKE 
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR: 1) REPLACEMENT OF THE POLYMIDE TUBING WITH POLYETHERETHERKTONE (PEEK) TUBING ON THE PULSE GENERATOR PG HEADER ASSEMBLIES; 2) THE USE OF A COMBINATION OF NATURAL AND COLORIZED PEEK TO ASSIST MANUFACTURING OPERATORS; AND 3) THE ADDITION OF AN EXTRA PLASMA CLEANING STEP TO ENSURE THAT THE BOND FORMED BETWEEN THE MEDICAL ADHESIVE APPLIED TO THE BASE OF THE WIRE AND THE PEEK INSULATION IS STRONG.
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