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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.
 
DeviceSTELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP020030
Supplement NumberS001
Date Received07/16/2004
Decision Date11/22/2004
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF THE EASYTURN DEPLOYMENT MECHANISM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASYTURN AND IS INDICTED FOR USE WITH AN IMPLANTABLE PACEMAKER. THEY ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.
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