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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 DEFIBRILLATION LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP950022
Supplement NumberS017
Date Received06/09/2003
Decision Date07/01/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a fluoroscopic marker in the helix tip and the addition of new lead lengths and minor modifications to the suture sleeve. The leads are indicated for permanent sensing and pacing in either the atrium or the ventricle, in combination with a compatible pulse generator.
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