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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
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/material
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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