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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP020030
Date Received07/19/2002
Decision Date06/17/2004
Product Code NVN 
Docket Number 04M-0310
Notice Date 07/16/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE STELID II, STELIX, AND STELIX II ENDOCARDIAL PACING LEADS. THE STELID II, STELIX, AND STELIX II ENDOCARDIAL STEROID ELUTING PACING LEADS ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART. THE STELID II MODELS BTF25D/26D AND UTF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE. THE STELID II MODELS BJF24D/25D, STELIX MODELS BR45D/46D, AND STELIX II MODELS BRF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 
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