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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 CD/EASYTRAK LEADS & ACCESSORIES
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS006
Date Received11/13/2002
Decision Date12/13/2002
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.
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