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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 II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP020030
Supplement NumberS003
Date Received05/25/2006
Decision Date07/12/2006
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE HELIX MECHANISM, ADDITION OF RADIOPAQUE MARKERS, AND MODIFICATIONS TO THE DEVICE INSPECTION PROCEDURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASY TURN MODELS BRF24D, BRF25D, AND BRF26D AND ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART.
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