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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 OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS030
Date Received06/05/2006
Decision Date07/07/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to place an overlay over the silicone lead body of the riata st leads to create the new riata st optim lead models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 and are indicated for use with compatible pulse generators.
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