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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSTELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nameednocardial pacing lead
ApplicantSORIN GROUP- CRM
PMA NumberP020030
Date Received07/19/2002
Decision Date06/17/2004
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 04M-0310
Notice Date 07/16/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
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