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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 LEAD, REVO MRI IPG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS091
Date Received04/10/2013
Decision Date12/24/2013
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
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