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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 NameMEDTRONIC EN-TRUST 30J/35J ICD FAMILY
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS067
Date Received01/24/2006
Decision Date03/02/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor design change to the icr (interconnect ribbon) that connects the feedthroughs to the connector module blocks and multi beam contacts for the medtronic entrust 30j/35j icd family (d153atg, d153drg, d153vrc, d154atg, d154drg, d154vrc). Specifically, the interconnect ribbon (icr) that connects the feedthroughs to the connector module blocks and multi beam contacts is being modified to provide a lap-weld joint and the bonding of the same materials.
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