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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 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Nameversion 3.7nchronization therapy-defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS023
Date Received01/16/2004
Decision Date03/09/2004
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 firmware modifications of the following aicd systems: ventak prizm aicd system (models 1850, 1851, 1855, 1856) firmware version 1. 2 patch h, ventak prizm he aicd system (models 1852, 1853, 1857, 1858) firmware version 1. 2 patch h, ventak prizm 2 aicd system (models 1860, 1861) firmware version 1. 4 patch c, vitality ds/el aicd system (models t125, t127, t135) firmware version 1. 0 patch b, contak cd 2 (models h115, h119) firmware version 1. 2 patch h, and the application software model 2844 version 3. 7.
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