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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 STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS040
Date Received07/06/2007
Decision Date09/06/2007
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DISTAL TIP CHANGES TO THE RIATA ST OPTIM LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA STS OPTIM LEAD MODELS 7120, 7121, 7122, 7130 AND 7131, AND ARE INDICATED FOR USE AS TRANSVENOUS, STEROID ELUTING, RIGHT VENTRICULAR DUAL AND SINGLE DEFIBRILLATION COIL LEADS WITH COMPATIBLE PULSE GENERATORS.
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