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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.
 
DeviceMODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2)
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 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/material
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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