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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.
 
DeviceST.JUDE MEDICAL ICDS/CRT-DS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS011
Date Received07/29/2005
Decision Date12/16/2005
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ELIMINATION OF AN EXTRA LAYER OF PARYLENE COATING THAT IS APPLIED OVER THE HIGH VOLTAGE CAPACITOR PRIOR TO ITS INSTALLATION INTO THE DEVICE ASSEMBLY DURING THE ICD/CRT-D MANUFACTURING.
Post-Approval StudyShow Report Schedule and Study Progress
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