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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 NameMODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2)
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namepacing lead suture sleeve
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS012
Date Received04/24/2003
Decision Date07/02/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 2848 contak cd programmer software application, version 3. 2.
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