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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.
 
DeviceREVO MRI
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS019
Date Received04/25/2011
Decision Date05/26/2011
Product Codes LWP NVN NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
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