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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP950022
Supplement NumberS025
Date Received05/31/2005
Decision Date11/04/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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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