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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 SERIES 1500 DEFIBRILLATION LEAD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS014
Date Received01/31/2002
Decision Date03/11/2002
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 NEW DEFIBRILLATION LEAD SYSTEMS AND ACCESSORIES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIAT SERIES 1500 (MODELS 1570, 1571, 1580 AND 1581) DEFIBRILLATION LEAD SYSTEM AND ACCESSORIES (S-65-S, S-65-F, S-65-X, TX-070). THESE DEVICES ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUAL FOR SYSTEM INDICATIONS.). THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/DEFIBRILLATION THERAPY TO THE HEART.
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