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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.
 
DeviceKAPPA 400 DR/SR IPG
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS068
Date Received05/17/2010
Decision Date03/22/2011
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
Approval OrderApproval Order
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