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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 ST LEAD MODELS 7000, 7001, AND 7002
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP950022
Supplement NumberS024
Date Received04/21/2005
Decision Date06/03/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of the riata st lead models 7000, 7001, and 7002 to the riata defibrillation lead system. The devices, as modified, will be marketed under the trade name riata st models 7000, 7001, and 7002 and are indicated for use with compatible pulse generators.
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