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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 NameST.JUDE MEDICAL ICDS/CRT-D
Classification Nameimplantable pacemaker pulse-generator
Generic Nametranstelephonic follow-up/monitoring system
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS080
Date Received08/02/2005
Decision Date12/16/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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.
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