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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.
 
DeviceCURRENT ICD'S
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS050
Date Received04/06/2007
Decision Date09/11/2007
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING THE WIRELESS COMMUNICATION BETWEEN THE PROGRAMMER AND THE IMPLANTABLE DEVICES.
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