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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
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS295
Date Received11/21/2018
Decision Date12/17/2018
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Transfer an intermediate manufacturing step to fill Dexamethasone Sodium Phosphate and Dexamethasone Acetate into vials from Medtronic Energy and Component Center to the Medtronic Cardiac Rhythm Heart Failure Rice Creek Pharma Manufacturing Operations facility and to implement minor process improvements.
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