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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 SURE AND SCAN LEAD
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS164
Date Received12/08/2014
Decision Date03/18/2016
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
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