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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.
 
DeviceINSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD
Generic Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS363
Date Received02/26/2013
Decision Date05/24/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
Approval OrderApproval Order
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