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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 NameCONTAK RENEWAL TR
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantGUIDANT CORP.
PMA NumberP030005
Supplement NumberS039
Date Received11/01/2006
Decision Date02/08/2007
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the guidant pulse generator replacement guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life.
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