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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS030
Date Received06/05/2006
Decision Date07/07/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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