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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.
 
DeviceSTELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP020030
Supplement NumberS004
Date Received10/11/2007
Decision Date10/17/2008
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A CHANGE INVOLVING ALTERNATE PROCESS PARAMETERS FOR THE MANUFACTURING OF MATERIALS IN THE STEROID COLLAR COMPONENTS.
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