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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.
 
DeviceST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS025
Date Received05/31/2005
Decision Date11/04/2005
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SIX LEAD MODELS WITH ELAST-EON 2A LEAD BODY INSULATION MATERIAL TO THE ST. JUDE MEDICAL RIATA/RIATA I DEFIBRILLATION LEAD SYSTEM.
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