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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.
 
DeviceTENDRIL ST LEAD MODELS 1888TC AND 1882TC
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS018
Date Received04/13/2006
Decision Date06/06/2006
Product Codes NVY NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE LEAD INSULATION ON THE TENDRIL ST 1788T/TC AND TENDRIL ST 1782 LEADS, AND TO REDUCE THE OUTER COIL WIRE DIAMETER ON THE TENDRIL ST 1782 LEAD. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST LEAD MODEL 1888TC AND TENDRIL ST LEAD MODEL 1882TC. THE TENDRIL ST LEAD MODEL 1888TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST LEAD MODEL 1882TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
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