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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 LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS032
Date Received11/02/2006
Decision Date12/14/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A HELIX ATTACHMENT MODIFICATION FOR THE RIATA 1580, 1581 AND 1582 LEADS AS WELL AS A CRIMP-WELD COUPLING MODIFICATION FOR THE RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES.
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