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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Namecardiovascular permanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP960013
Supplement NumberS010
Date Received03/06/2002
Decision Date03/27/2002
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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