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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.
 
DevicePROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II 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 NumberS280
Date Received02/09/2011
Decision Date05/02/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MEDTRONIC PROTECTA¿ XT VR D314VRM, PROTECTA¿ VR D334VRM, SECURA® VR D204VRM, MAXIMO II® VR D264VRM ICD SYSTEMS, MODEL 9995 APPLICATION SOFTWARE V7.3 AND MODEL SW009 APPLICATION SOFTWARE VL.0 SYSTEMS.
Approval OrderApproval Order
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