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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.
 
DeviceENTOVIS PROMRI PACEMAKER SYSTEM
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS132
Date Received11/25/2013
Decision Date05/04/2014
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT01761162
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
Approval OrderApproval Order
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