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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.
 
DeviceMAXIMO II DF4CRT-D,MAXIMO II DF4 ICD,MAXIMO II ICD,PROTECTA DF4 ICD,PROTECTA ICD,PROTECTA XT DF4 ICD,PROTECTA XT ICD
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 NumberS384
Date Received09/27/2012
Decision Date11/02/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN UPDATE TO THE RAW MATERIAL OF THE CAPACITORS USED IN THE HIGH VOLTAGE DELIVERY CIRCUITRY.
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