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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.
 
DeviceMEDTRONIC EN-TRUST 30J/35J ICD FAMILY
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS067
Date Received01/23/2006
Decision Date03/02/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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