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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 LEAD MODELS 7000, 7001, AND 7002
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS024
Date Received04/21/2005
Decision Date06/03/2005
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 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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