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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 ATTAIN STARFIX MODEL 4195 LEADS
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP060039
Supplement NumberS056
Date Received02/07/2014
Decision Date08/04/2014
Product Code OJX 
Advisory Committee Cardiovascular
Clinical TrialsNCT00893386
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
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