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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.
 
DeviceST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS017
Date Received06/09/2003
Decision Date07/01/2003
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 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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