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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, MODELS H120, H125
Classification Namepermanent pacemaker electrode
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP030005
Supplement NumberS001
Date Received02/04/2004
Decision Date03/03/2004
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the method that is used to release sterilized product, from the use of biological indicators to parametric release.
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