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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.
 
DeviceCAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS226
Date Received05/03/2016
Decision Date10/25/2016
Product Codes LWP NVN 
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
Approval Order Statement  
Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
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