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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 2 CRT-D SYSTEMS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy defibrillator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS011
Date Received03/17/2003
Decision Date07/10/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the programmer software application model 2844 version 3. 6.
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