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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 DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS
Generic Namepermanent pacemaker Electrode
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS010
Date Received03/06/2002
Decision Date03/27/2002
Product Codes DTB DXY 
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 THE LOCATOR STEERABLE STYLET MODEL 4036 FOR USE WITH TENDRIL DX MODEL 1388 T/TC/K AND TENDRIL SDX MODEL 1488 T/TC/K ENDOCARDIAL PACING LEADS.
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