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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 NameRIATA DEFIBRILLATION LEAD FAMILY
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP950022
Supplement NumberS018
Date Received03/11/2004
Decision Date04/21/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the riata defibrillation lead family to include integrated bipolar leads (models 1560, 1561, 1562, 1590, 1591 and 1592).
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