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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 SureScan and CapSureFix MRI SureScan Lead
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS281
Date Received04/13/2018
Decision Date06/28/2018
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Clinical TrialsNCT00433654
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.
Post-Approval StudyShow Report Schedule and Study Progress
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