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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 ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VR
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS300
Date Received04/06/2012
Decision Date05/04/2012
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
SOFTWARE UPGRADE TO AN EXISTING TEST EQUIPMENT.
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