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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 PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS028
Date Received02/13/2006
Decision Date03/07/2006
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: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL. 2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS. 3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
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