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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.
 
DeviceMEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP930039
Supplement NumberS107
Date Received04/17/2014
Decision Date10/13/2014
Product Code NVN 
Advisory Committee Cardiovascular
Clinical TrialsNCT01755143
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING THE 5076 CAPSUREFIX NOVUS LEAD TO THE MR CONDITIONALPACING FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 AND IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A MEDTRONIC MRI SURESCAN IPG IMPLANTED WITH SURESCAN LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THEMRI ENVIRONMENT.
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